Catalyst Recruiting Group » All Jobs

Principal Mechanical Design Engineer

greg — Sun, 05 Feb 2012 17:10:10 +0000

Marietta, GA- The Catalyst Recruiting Group www.catgroupinc.com is representing a growing advanced medical device manufacturer in the greater Marietta, GA area. Due to growth, they have an immediate need for Principal Mechanical Design Engineer that will be a part of an advanced medical device R&D Team. This is a fast paced group that will work cross functionally developing cutting edge products. This role will work with KOL’s (Physicians and Surgeons) to develop novel intellectual property through design input requirements, prototyping engineering studies (build and test product) feasability studies and protocol/report writing to support regulatory submissions/risk analysis (leader of DFMEA’s.) This position will be the subject matter expert for mechanical design enhancement and design improvements through reverse engineering for next generation products that will be applied in vitro, in situ, in vivo, and ex vivo tests to tissues, organs, and organisms.

ABSOLUTELY REQUIRED: BS Mechancial Engineering. 8+ years developoing advanced medical devices. Advaced laser theory. Advanced experience with 3D CAD models and 2D engineering drawings with Solidworks (not Pro-E or other design tools…must be Solidworks). Drafting Standards (ASME Y14.5-2009). DOE. Project Management

If you have ALL of the required qualifications for this position and are skeptical about sending in a resume to someone you have never spoken with, give us a call. We try to rise above the recruiting rhetoric by giving our contact information in order to provide you as much information as possible. We go to great lengths to work directly with the hiring managers for the positions we represent so our job descriptions truly reflect the needs of the organization.

Greg Giltner
greg@catgroupinc.com
803-622-0285
www.linkedin.com/in/giltner

Principal Embedded Software Engineer

greg — Sun, 05 Feb 2012 16:52:20 +0000

Carlsbad, CA- The Catalyst Recruiting Group www.catgroupinc.com is representing a growing advanced medical device manufacturer in the greater Carlsbad, CA area. Due to growth, they have an immediate need for Senior Software Engineer that will be a part of an advanced medical device R&D software team. This is a fast paced group that will work cross funcitonally in a “state of the art” facility making cutting edge products. Their proprietary software is in such demand, it is licensed to other advanced medical device companies. This role will be responsible for taking ownership of specific subsystems to drive the requirements, design, implementation, and testing Additionally, this person will need to have quantifiable experience within a defined development process. Although an indvidual contributor, the Senior Software Engineer will be a leadership role.

ABSOLUTELY REQUIRED: - BS in Computer Science. 5+ years of full software life cycle development/analysis and design skills with an emphsis in C++, C# in embedded systems and communication protocols. Risk Management, V&V Testing. Developoment Studio, and Microsoft.NET

Greg Giltner
greg@catgroupinc.com
803-622-0285
www.linkedin.com/in/giltner

Sr. Equipment Project Engineer

greg — Sun, 05 Feb 2012 16:51:25 +0000

Daytona, Florida -The Catalyst Group www.catgroupinc.com is working with a growing, multi-national medical device client in their search for a Senior Mechanical Engineer for a one of their largest manufacturing facilities. This role will implement continuous improvements and specify new machinery and equipment including design and development when needed while providing necessary leadership for project engineers/techs. This role will also analyze required changes to achieve increased production output and/or reduce product/process defects and waste and rely on someone’s ability to redesign existing machine components to improve performance. A snapshot includes: Project Management of Capital Expenditure Request (CER) projects, project definition, capital and expense estimates, and project timeline. Mechanical design for safety, quality, efficiency, and reliability. Technical documentation, spending schedules, resource requirements, system mechanical drawings, and as-built assembly drawings, validations. Use and understanding of statistical based software and quality tools (i.e., Process Maps, C&E Matrix, FMEA, and Design of Experiments) for warranting process changes or continuous improvements. CAD. Engineering Change Requests (ECRs). Validation protocols.

REQUIRED: :Bachelor’s degree in Mechanical Engineering. 5+ years of hands-on, plant level equipment engineering in an FDA regulated industry. Autocad, Design Works or similar design program. You might want to read those previous two lines again because they are required, no exceptions, by the powers that be. Autocad or a similar package.

This position is going to be highly visible within this facility. They are looking for someone that can motivate people, drive change and fully reflect the corporate goals/initiatives for lean manufacturing and continuous improvement. This is a role for a strategic planner that has quantifiable examples of affecting the bottom line, accessing risk through root cause analysis and acting as a “change agent” through an organization.

This company offers an outstanding benefits package, bonus potential and a full relocation package. This is a global company, very stable and growing organically and through M&A.

After confirming that you meet the qualifications listed above, please send an email referencing this position title and location along with a WORD version of your resume and current/last base salary information to greg@catgroupinc.com. This information will be kept confidential and will allow our team to better understand the level and direction of your search. Under no circumstances will we submit your resume without your approval.

To apply, please email resume and current/last base salary to:

Greg Giltner
greg@catgroupinc.com
803-622-0285
www.linkedin.com/in/giltner

Senior Quality Assurance Engineer-High Speed Manufacturing

greg — Sun, 05 Feb 2012 16:50:31 +0000

Daytona,Fla- The Catalyst Recruiting Group www.catgroupinc.com is proud to be working with a growing medical device/products client in the Greater Daytona, Florida area who is expanding and looking for a Senior Quality Engineer. This position will take responsibility for quality engineering functions within the manufacturing facility by assisting in developing, implementing and administering quality specifications, test methodologies, and sampling plans for product and process. This role will work cross functionally with. This position works directly with manufacturing, R&D and engineering to assure quality is covered in the design, testing, and release of materials, components and completed products. Position is expected to have an expert level understanding of FDA regulations and ISO 13485, MDD and CMDR requirements; provide quality-engineering expertise for the continuous improvement of product and process and provide engineering input for corrective and preventative action for in-house and customer reported problems. Participation in internal audits, supplier audits, and assessments by external parties is expected. Position is expected to function as a problem solver, capable of analyzing problems and implementing root cause elimination solutions. Position maintains primary responsibility for critical quality systems as delegated by the Quality Manager, which can include the internal audit program, CAPA system, environmental monitoring, and OEM customer support. This position is responsible for assuring overall regulatory compliance to the QSR and applicable Quality System standards. to both product design requirements, internal standards and external standards.

REQUIRED Completed 4 year degree, no exceptions, corporate policy. At least 6 years in an FDA regulated industry in a Quality Assurance function recently in a manufacturing environment; preferably in a high volume, automated manufacturing environment in a regulated industry. Supervisory experience

Highly Desired Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) credential desired. Six Sigma or Lean training desired.

After confirming that you meet the qualifications listed above, please send an email referencing this position title and location along with your resume and current/last base salary information to greg@catgroupinc.com. This information will be kept confidential and will allow our team to better understand the level and direction of your search. Under no circumstances will we submit your resume without your approval.

To apply, please email resume and current/last base salary to:

Greg Giltner
greg@catgroupinc.com
803-622-0285
www.linkedin.com/in/giltner

Quality Assurance Manager-Medical

greg — Sun, 05 Feb 2012 16:49:34 +0000

Salt Lake City, UT- The Catalyst Recruiting Group www.catgroupinc.com is proud to be working with a growing and diverse global Fortune 1000 medical device and equipment manufacturing company. This company is a leader in their industry with over $2 billion in annual revenues and a very diverse product line. We are assisting them with their search for a Quality Engineering Manager for the Salt Lake City, UT location. This position is within the new product development (NPD) area. In addition this position will act as a technical expert within the QA group, providing support for projects that require quality engineering. This role will work cross functionally with manufacturing, R&D and engineering to assure quality is covered in the design, testing, and release of materials, components and completed products. The ideal candidate must be able to work in an extremely fast paced environment. Have experience developing qualification and feasibility studies for new products and product improvements. Must be able to develop and implement new Standard Operating Procedures.

REQUIRED Bachelors Degree in Engineering plus 7 years of related experience in Manufacturing/Quality environment. Must be able to demonstrate/verify a high level of leadership.

Highly Desired Experience in Medical Device Manufacturing or related industry. Masters degree in Engineering. ASQ-CQE, CQM or CRE.

This company offers an outstanding benefits package and a relocation package for this position. This is a global company, very stable and growing organically and through M&A.

After confirming that you meet the qualifications listed above, please send an email referencing this position title and location along with your resume and current/last base salary information to jon@catgroupinc.com. This information will be kept confidential and will allow our team to better understand the level and direction of your search. Under no circumstances will we submit your resume without your approval.

To apply, please email resume and current/last base salary to:

Jon Leifer
jon@catgroupinc.com
843-670-1619

Sr. Advanced R&D Engineer-Medical Device

greg — Sun, 05 Feb 2012 16:48:37 +0000

Salt Lake City, UT- The Catalyst Recruiting Group www.catgroupinc.com is proud to be working with a growing and diverse global Fortune 1000 medical device and equipment manufacturing company. This company is a leader in their industry with over $2 billion in annual revenues and a very diverse product line. We are assisting them with their search for a Sr. Engineer for the Salt Lake City, UT location. This position is responsible for concept generation, design, development and evaluation of new products, materials and technologies. The position is also responsible for execution and control of the project through closure. Must be able to create, analyze and optimize manufacturing and quality systems, create and critique engineering cost analysis. Candidate must be able to work in an extremely fast paced environment.

REQUIRED Bachelors Degree in Engineering plus 6 years of engineering experience in medical device or equivalent industry
OR
Masters degree in engineering with 3 years of engineering experience in medical device or equivalent industry.

This is a global company, very stable and growing organically and through M&A and offers an outstanding benefits package.

After confirming that you meet the qualifications listed above, please send an email referencing this position title and location along with your resume and current/last base salary information to jon@catgroupinc.com. This information will be kept confidential and will allow our team to better understand the level and direction of your search. Under no circumstances will we submit your resume without your approval.

To apply, please email resume and current/last base salary to:

Jon Leifer
jon@catgroupinc.com
843-670-1619

Project Engineer-Medical Device

greg — Sun, 05 Feb 2012 16:47:25 +0000

Salt Lake City, UT- The Catalyst Recruiting Group www.catgroupinc.com is proud to be working with a growing and diverse global Fortune 1000 medical device and equipment manufacturing company. This company is a leader in their industry with over $2 billion in annual revenues and a very diverse product line. We are assisting them with their search for an Engineer II for the Salt Lake City, UT location. This position is responsible conducting engineering studies for process improvements and validations. This position designs, develops and implements new products, processes, testing methods and equipment. This position will also provide technical support on components, materials methods, systems and equipment. As well as write and approve protocols and test methods. Must be able to prepare and submit for approval requests for project funding and participate in project planning, budgeting, scheduling and tracking. Candidate must be able to work in an extremely fast paced environment.

REQUIRED Associate technical degree with 8 years of engineering experience within the medical device or equivalent regulated industry
OR
Bachelor degree in engineering with 4 years of engineering experience within the medical device or equivalent regulated industry
OR
Masters degree in engineering with 3 years of engineering experience within the medical device or equivalent regulated industry

This is a global company, very stable and growing organically and through M&A and offers an outstanding benefits package.

After confirming that you meet the qualifications listed above, please send an email referencing this position title and location along with your resume and current/last base salary information to jon@catgroupinc.com. This information will be kept confidential and will allow our team to better understand the level and direction of your search. Under no circumstances will we submit your resume without your approval.

To apply, please email resume and current/last base salary to:

Jon Leifer
jon@catgroupinc.com
843-670-1619

Sr. Quality Assurance Engineer-NPD

greg — Sun, 05 Feb 2012 16:43:11 +0000

Salt Lake City, UT- The Catalyst Recruiting Group www.catgroupinc.com is proud to be working with a growing and diverse global Fortune 1000 medical device and equipment manufacturing company. This company is a leader in their industry with over $2 billion in annual revenues and a very diverse product line. We are assisting them with their search for a Sr. Quality Engineering for the Salt Lake City, UT location. This position is responsible for systems assurance including documentation, testing and inspection, product and process development, and non-conforming product investigations. This positions works cross functionally across, Manufacturing, New Product Development and Regulatory to ensure systems are in compliance with internal and external guidelines. Must have experience managing and developing validation studies on equipment and processes. Must have basic tooling design and drafting knowledge. The candidate must be able to work in an extremely fast paced environment.

REQUIRED Bachelors Degree in Engineering plus 6 years of engineering experience in medical device or equivalent industry
OR
Masters degree in engineering with 5 years of engineering experience in medical device or equivalent industry. Experience must include 3 years of proven and effective project management skills as well as design and risk assessment (FMEA, statistical analysis) and DOE

This is a global company, very stable and growing organically and through M&A and offers an outstanding benefits package.

After confirming that you meet the qualifications listed above, please send an email referencing this position title and location along with your resume and current/last base salary information to jon@catgroupinc.com. This information will be kept confidential and will allow our team to better understand the level and direction of your search. Under no circumstances will we submit your resume without your approval.

To apply, please email resume and current/last base salary to:

Jon Leifer
jon@catgroupinc.com
843-670-1619

Senior Medical Device Quality Engineer

greg — Sun, 05 Feb 2012 16:42:00 +0000

Springfield, MA- The Catalyst Recruiting Group www.catgroupinc.com is working with a growing, multi-national medical device client in their search for an innovative Senior Plant Quality Engineer This role will develop, implement and administer quality specifications, test methodologies, and sampling plans for product and process. Typical accountability:

Manage CAPA program and follow up on CAPA actions and due dates. Determine root cause/corrective and/or preventive actions for CAPAs. Mentor CAPA champion and team members.
Manage SCAR program, initiate SCARs, and track SCAR corrective actions and due dates.
Perform supplier audits and initiate/monitor follow up actions as required
Determine root cause/corrective and/or preventive action for customer complaints and externally generated customer SCARs
Six Sigma/Lean/Cost Savings Support
Manage and/or participate on quality improvement projects including collaboration with R&D, Marketing, Regulatory, Stability Services, and Clinical Affairs. Support cost savings projects. Use of statistical tools to perform analysis and data trending. Perform process risk assessment and failure mode effects analysis (PFMEA). Develop specifications and test methods to meet customer, product and internal quality requirements. This may include writing procedures to carry out requirements. Review new and modified product designs and processes for quality compliance.
Position maintains primary responsibility for critical quality systems including the internal audit program, CAPA system, and control of non-conforming product. This position is responsible for assuring overall regulatory compliance to the QSR and applicable Quality System standards.

REQUIRED Bachelors Degree. MDD and CMDR experience preferred. Project Management, SPC, DOE, FMEA

This position is going to be highly visible within this facility. They are looking for someone that can provide innovative problem solving abilities, motivate people, drive change and fully reflect the corporate goals/initiatives for lean manufacturing and continuous improvement. This is a role for a strategic planner that has quantifiable examples of affecting the bottom line, accessing risk through root cause analysis and acting as a “change agent” through an organization.

Our client is growing steadily both organically and though M&A. They are a global organization that offers outstanding growth potential. The benefits are outstanding and include generous 401k match, full tuition reimbursement, ESOP and much more. Relocation is being offered for this position.

After confirming that you meet the qualifications listed above, please send an email referencing this position title and location along with your resume and current/last base salary information to jon@catgroupinc.com. This information will be kept confidential and will allow our team to better understand the level and direction of your search. Under no circumstances will we submit your resume without your approval.

To apply, please email resume and current/last base salary to:

Jon Leifer
jon@catgroupinc.com
843-670-1619

Supply Chain Buyer-Planner-Manufacturing

greg — Sun, 05 Feb 2012 16:40:44 +0000

Springfield, MA- The Catalyst Recruiting Group www.catgroupinc.com is proud to be working with a growing advanced manufacturer in the Springfield, MA area who has promoted from within opening a Buyer position. This buyer will be focused on the manufacturing lifecycle of a specific product group within this site which will include raw materials purchasing. This role will work directly under the manufacturing manager in a small supply chain department. They are targeting that “go getter mentality” with outstanding communication ability and drive to take ownership.

REQUIRED 4 year degree, no exceptions, company policy. Quantifiable experience in manufacturing supply chain.

After confirming that you meet the qualifications listed above, please send an email referencing this position title and location along with your resume and current/last base salary information to jon@catgroupinc.com. This information will be kept confidential and will allow our team to better understand the level and direction of your search. Under no circumstances will we submit your resume without your approval.

To apply, please email resume and current/last base salary to:

Jon Leifer
jon@catgroupinc.com
843-670-1619

Quality Engineering Manager

greg — Tue, 31 Jan 2012 14:25:29 +0000

Atlanta, GA-The Catalyst Group www.catgroupinc.com working with a 7 Billion/year, 11,000 person medical device company located in the Atlanta Georgia area. They have engaged our services to identify a Quality Engineering Manager that will manage a group that provides quality engineering leadership for new product development and transfer to manufacturing while performing internal or supplier quality system audits. This role will lead in identification of device specific regulatory and performance standards that should be used in the formulation of the design input requirements Review and approve design input requirements. Lead in Development of Risk Management Documentations to include DFMEA. Review and approve the IQ, OQ, & PQ protocols, DMR and test methods.

REQUIREDCompleted 4 year degree in science or engineering, no exceptions. 10 years of progressive experience in quality engineering with several recent years of experience in the medical device arena. CQE or CQM. Document Control practices. Medical device quality systems regulation, industry or international standard, including management responsibility. Ability to interface with regulatory bodies to present technical information. Writing protocols/validations and has fundamental knowledge of validation principles. Applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi. Comprehensive understanding of auditing principles and ability to perform as a lead auditor.

Our client offers an outstanding career path, relocation, great benefits and dedicated culture focused on one thing-growth. They have recently obtained double digit growth (09 aside) and are on task to continue this.

Greg Giltner
greg@catgroupinc.com
803-622-0285
www.linkedin.com/in/giltner

Quality Assurance Engineer-High Volume FDA

greg — Sun, 29 Jan 2012 16:15:52 +0000

Daytona,Fla- The Catalyst Recruiting Group www.catgroupinc.com is proud to be working with a growing medical device/products client in the Greater Daytona, Florida area who is expanding and looking for a Quality Engineer. This position will take responsibility for quality engineering functions within the manufacturing facility by assisting in developing, implementing and administering quality specifications, test methodologies, and sampling plans for product and process. This role will work cross functionally with. This position works directly with manufacturing, R&D and engineering to assure quality is covered in the design, testing, and release of materials, components and completed products. This role will provide quality-engineering expertise for the continuous improvement of product and process and provide engineering input for corrective and preventative action for in-house and customer reported problems. Participation in internal audits, supplier audits, and assessments by external parties is expected. Position is expected to function as a problem solver, capable of analyzing problems and implementing root cause elimination solutions. Position maintains primary responsibility for critical quality systems as delegated by the Quality Manager, which can include the internal audit program, CAPA system, environmental monitoring, and OEM customer support. This position is responsible for assuring overall regulatory compliance to the QSR and applicable Quality System standards. to both product design requirements, internal standards and external standards.

REQUIRED Completed 4 year degree, no exceptions, corporate policy. At least 2 years in an FDA regulated industry in a Quality Assurance function recently in a manufacturing environment; preferably in a high volume, automated manufacturing environment in a regulated industry.

Highly Desired Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) credential desired. Six Sigma or Lean training desired.

To apply, please email resume and current/last base salary to:

Greg Giltner
greg@catgroupinc.com
803-622-0285
www.linkedin.com/in/giltner

Manager Quality Engineering-High Volume Medical

greg — Sun, 29 Jan 2012 16:13:33 +0000

Daytona,Fla- The Catalyst Recruiting Group www.catgroupinc.com is proud to be working with a growing medical device/products client in the Greater Daytona, Florida area who is expanding and looking for a Manager of Quality Engineering. This position will take responsibility for quality engineering functions within the manufacturing facility by developing, implementing and administering quality specifications, test methodologies, and sampling plans for product and process. This position works directly with manufacturing, R&D and engineering to assure quality is covered in the design, testing, and release of materials, components and completed products. This role will provide quality-engineering expertise for the continuous improvement of product and process and provide engineering input for corrective and preventative action for in-house and customer reported problems. Participation in internal audits, supplier audits, and assessments by external parties is expected. Position is expected to function as a problem solver, capable of analyzing problems and implementing root cause elimination solutions. Position maintains primary responsibility for critical quality systems as delegated , which will include the internal audit program, CAPA system, environmental monitoring, and OEM customer support. This position is responsible for assuring overall regulatory compliance to the QSR and applicable Quality System standards. to both product design requirements, internal standards and external standards. This role will have up to 30 direct and indirect reports

REQUIRED 4 year degree, Medical Device quality experience in high volume manufacturing. A strong, quantifiable “change agent” management background. 6 Sigma or a flavor of lean manufacturing. FDA Inspection experience.

Highly Desired Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) credential desired. Six Sigma or Lean training desired.

To apply, please email resume and current/last base salary to:

Greg Giltner
greg@catgroupinc.com
803-622-0285
www.linkedin.com/in/giltner

FPGA Design Manager

greg — Tue, 18 Oct 2011 13:13:33 +0000

Boulder, CO- The Catalyst Recruiting Group www.catgroupinc.com is proud to be working with a growing advanced medical device client in the Greater Boulder area who is expanding and looking for a R&D Manager. The R&D Manager will be functionally responsible for the management of 6+ R&D Electrical Engineers at varying levels (principal, senior etc). The goal of this group is to innovate new technology which leads to new products or process development. This will involve the full R&D life-cycle from prototype to product introduction including but not limited to: group/technical vision, project management/scheduling, budgets, engineering documentation in an RTL in an Embedded Firmware platform

REQUIRED BS/MS Electrical Engineering (no exceptions…no really, straight from the hiring manager’s mouth). Recent, quantifiable experience as a functional manager in R&D in an ASIC environment. MS Project. Design for Manufacturability. Block level architecture design. Synthesis, Static Timing Analysis, DFT of RTL(register transfer level), Embedded Firmware .VLSI projects. Engineering change documents Verilog, scripting (Perl, python, Tcl, shell), SystemVerilog, and C/C++,VHDL, OVM. Strong background in SVA, covergroups, and constrained random is required. Communication systems and high speed digital circuit design. FPGA design process and tools.

Highly Desired Medical Device Software. Advanced degree.

Our client offers outstanding compensation, full relocation and a strong benefits package. This is a global organization with a strong history of R&D and is positioned to double in size through new product introduction and M&A.

To apply, please email resume and current/last base salary to:

Greg Giltner
greg@catgroupinc.com
803-622-0285
www.linkedin.com/in/giltner