Principle Design Quality Engineer Medical Devices

  • Location
    Mansfield, Massachusetts
  • Job type
  • Category
    Engineering - Quality

Adecco is currently assisting our local client in finding a highly experienced Principle Design Quality Engineer in Mansfield, MA. APPLY NOW if you meet the qualifications below:

Must be eligible to work for any employer in the U.S. without sponsorship - No corp to corp arrangements

Job Title: Principle Design Quality Engineer
Location: Mansfield, MA - No relocation assitance, per diem, or other expense reimbursement can be offered
Targeted Pay Rate: up to $52.88 per hour / depending on experience
Estimated Duration (in months): 1 year
Total Weekly Hours: 40
Shift: 1st - Monday thru Friday

*****Resources must be local to Mansfied, MA - no travel expenses allotted and they must be onsite Monday-Friday 8am-5pm

Description of Work:
This position is for a Principal Design Quality Engineer with hands on experience and proven success supporting new product development activities. This position offers opportunity to lead DQE initiatives and provides exposure to multiple projects. The candidate will lead and support NPD projects to ensure desired design and product performance levels are met in compliance with all applicable regulatory requirements and Covidien Policies and Procedures.

The candidate will have demonstrated proficient experience with quality engineering concepts, including but not limited to design control, risk management, supplier quality, and continuous improvement. The candidate must also demonstrate consistent good decision making skills and will have the experience to proactively identify and lead business development opportunities or address issues outside of their core responsibilities with minimal supervision. Additionally, the candidate will possess the critical behavioral skills integral to developing and strengthening productive relationships/partnerships.

• Support the development and manufacturing of medical devices in conformance with the Quality System Regulation, ISO 13485, Medical Device Directive, ISO 14971, IEC 60601 and other regulatory standards.
• Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
• Lead all risk management activities, ensure procedures and files are maintained to State of the Art, and ensure all applicable staff are sufficiently knowledgeable.
• Contribute to the streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative healthcare products.
• Provide guidance for the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements.
• Provide guidance and interpretation for industry related regulations within the framework of Covidien product and sustaining development processes.
• Interact and form constructive working relationships with all levels of leadership within Quality, Procurement, Marketing, R&D, and Operations.
• Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.

1. Act as a core team member providing leadership in identifying, developing, and/or performing all DQE deliverables defined by the Product Development process including but not limited to:
• Quality Plans (product and supplier)
• QFD’s
• Risk Management Plans and Reports
• Risk Assessments including Hazard Analyses and Risk Analyses
• FMEA’s (Design, Application, and Process)
• Risk based sampling plans
• Test method development and validation
• First Article Inspection’s and Reports
• Design Verification and Validation strategies and acceptance criteria
• Process Capability Analyses
• Post Market Surveillance analyses
• Failure Investigations
2. Lead/guide all extended quality functions (e.g. SQA, plant QA, PMV,) supporting NPD activities.
3. Ensure robust and complete project documentation (e.g., DHF).
4. Provide engineering expertise and support in supplier and internal auditing, external lab qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
5. Collaborate with plant QA and/or lead Quality Engineering initiatives for the Covidien manufacturing facilities associated with NPD projects, ensuring quality deliverables have been met.
6. Coordinate and lead product complaints investigations and CAPA’s.
7. Ensure all tasks are conducted in accordance with applicable regulatory standards and standard operating procedures.
8. Lead training initiatives in areas of subject matter expertise.
9. Other duties as assigned with or without accommodation.

Education required/ preferred:
B.S. in Engineering or associated scientific discipline.
Experience: Minimum 5 years medical devices experience in Quality or R&D Engineering position.

Preferred Skills/Qualifications:
• DFSS or DMAIC Black Belt Certified
• Certified Quality Engineer (CQE)
• Certified Quality Auditor (CQA)

• Proficient with Minitab
• Coaching and mentoring skills

Other Skills:
• Proven ability to directly lead and/or co-lead multiple tasks and projects.
• Strong understanding of industry expectations in the areas such as voice of customer, specification development, risk management, design verification and validation, stability studies, sterilization validation, biocompatibility, transportation testing, etc.
• Working knowledge of quality engineering principles, supplier management, and manufacturing operations within a regulated industry (preferably medical devices).
• Proficient with utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).
• Working knowledge of electro-mechanical devices, software validation methods, and/or plastics related manufacturing processes (i.e. extrusion, injection molding, RF welding, etc.) is preferred.
• Ability to interpret mechanical drawings.
• Familiar with gage and inspection techniques.
• Strong collaboration, negotiating, and conflict resolution skills.
• Fluid verbal and written communication skills.

The Principal DQE reports to the Design Quality Engineering Manager and will routinely interface/collaborate with multi-disciplined project team members, mangers, plant personnel, and suppliers. Periodic communication with external customers is also expected.

Disclaimer: We do not provide sponsorship for this opportunity. Candidates must now and in the future be legally eligible to work in the US for any employer without sponsorship or corp to corp arrangements.

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Reference number US_EN_2_022862_399596