Provide guidance of Design Controls and the PRP process to the engineering core teams
Recommend/promote new testing methodologies and approaches required to complete reliability analyses of device designs.
Provide guidance for development of manufacturing test/evaluation methods and process validation.
Key Areas of Responsibility
Integral member of product development team responsible for supporting activities required to ensure reliability of the design. Work closely with product development engineering, clinical, marketing and regulatory to assure appropriate reliability requirements are defined for the specific device application and target patient population.
Reviewing and approving clinical relevant test methods and Design Verification test plans, execution and reports. In collaboration with product development, recommending/promoting new testing methodologies and approaches required to complete reliability analyses of device designs.
Work with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability and reliability. Provide guidance for development of manufacturing test/evaluation methods and process validation.
Support and lead FMEA/Risk Management activities.
Support Post Market Product Assurance and audit groups in post-market activities
Work with a cross-functional, collaborative, team-based environment; work with multiple sites in various locations, time zones, and countries.
Serve as a team member technical resource for problem investigations to guide root cause analysis and corrective action development.
Essential requirements analysis including standards review and evidence of conformity.
Provide clear and regular technical and administrative input to professional, technical and administrative personnel assigned to a project.
Job Knowledge, Skills and Experience
Bachelor’s degree in engineering or science discipline
3-5 years experience in product development environment. Strong technical skills - provide solutions to a variety of technical problems of moderate scope and complexity
Demonstrated experience in reliability characterization and demonstration test methods, including establishing relevant test parameters and test sample sizes
Ability to learn quickly and respond to changing priorities
Regulatory compliance awareness, including at a minimum FDA design controls CFR 820, ISO 14971:2007, 13485: 2003 ISO9000 and ASME Pressure Vessel a plus
Demonstrated experience and understanding in use of statistical tools
Good verbal and written communication skills, good team skills including project management
Technical writing and presentation skills
Experienced with basic PC skills (MS Word, Excel, PowerPoint, and Project)
Desired/Preferred Qualifications
CRE / CQE Certification
DFLS / six sigma / DRM experience
Working knowledge of FEA simulation tools and analysis
Minitab experience
Strong statistics background
Experience with medical device regulations
Note: Philips is an equal opportunity employer
1099621
Philips Global - 13 months ago
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