Catalyst Recruiting Group » South East

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

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 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