Description
Design Assurance§ Serve as a Quality extended or core team member on new product development project teams.
§ Provide technical leadership for all quality deliverables defined by the Product Development process (PDP)
§ Support R&D and Operations during all product development phases.
§ Support creation of design controls (e.g. specification setting and justification, process instruction creation, receiving inspection).
§ Monitor design capability metrics to assure design robustness.
§ Actively participate in design reviews.
§ Lead the execution of all design verification and validation activities. Develop statistically sound design verification protocols and shelf life studies. Coordinate with all supporting functions (e.g. Test Lab, Microbiology, etc.) to meet project milestones. Oversee testing and write design verification reports.
§ Lead risk management activities. Create preliminary hazard analysis and Design-FMECA.
§ Assure all applicable quality decisions are derived from the appropriate risk management document in accordance to the quality system.
§ Lead or support cross functional root cause analysis teams with focus on design controls.
§ Serve as the design control guardian for proposed process changes; review and approve document change requests.
§ May support pilot production quality through application of the Medtronic CardioVascular quality system.
§ May support customer complaint analysis.
§ Mentor other engineers and technicians on the application of quality tools.
§ Anticipate roadblocks, provide direction for navigating the quality system and supporting applications.
§ Improve quality systems to achieve/maintain FDA facility registration, ISO certification and CE marking.
§ Stay abreast of applicable regulatory requirements. Actively seek out opportunities to understand current industry direction.
§ Assist Supplier Quality in developing qualified suppliers as needed.
§ Support the implementation of Design for Reliability and Manufacturability (DRM) on PDP projects.
§ Apply the DRM tools as applicable during quality activities milestones as part of the product development process.
Basic Qualifications
* BS Engineering, Chemistry, or Physics
* MS in Engineering desired
* A minimum of 5 years experience, with at least 3 years experience in the Medical Device industry
* A minimum of 3 years experience in product & process development
* Supervisory or management experience a plus
Desired/Preferred Qualifications
* ASQ Certified Quality Engineer or Six Sigma Black Belt a plus
* Internationally certified quality auditor designation a plus
Technical
Established experience with:
o Product development
o Design Controls
o Design Review
o Planning
o Risk Management
o Design verification and validation
o Test Method development and validation
o DOE
o Statistics
o ANOVA
o Confidence and Tolerance Limits
o SPC
o Process Development, Characterization, and Validation
o Process Improvement Tools
o Lean Manufacturing
o Six Sigma
o Combination drug/medical device products
o Strong in Chemical Engineering or Polymer Chemistry
o Able to solve very complex problems that require creativity
Conceptual
o Able to deliver on multiple projects simultaneously
o Ability for reasoning and logical deduction
o Ability to shift between abstract and concrete concepts
Interpersonal / Leadership
o Excellent prioritization and verbal/written skills
o Proficient at influencing subordinates, peers, and senior management
o Proven ability in coaching technical professionals to achieve maximum performance
o Self-directed
To find out more about Real Staffing please visit www.realstaffing.com