Product Development Engineer III (Design Assurance)
Position Summary: Responsible for providing support and guidance to new product development teams to assure the quality and reliability of new products. This position is responsible for ensuring the quality and reliability of new products through the appropriateness of design inputs, adequacy of verification and validation testing, and identification of key quality characteristics for the device. Additionally, this position is responsible for facilitating the risk management process and post market surveillance for new products.
Principle Responsibilities: (essential job duties and responsibilities)
- Participates and in some cases, leads in the development of Design Inputs: customer requirements/user needs, based on Voice of Customer (VOC) as appropriate, and engineering requirements. Ensures user needs can be validated and engineering requirements can be verified. Ensures requirements from Reliability Engineering and Standards Compliance Engineering are included in Design Inputs.
- Ensures adherence to the Risk Management Process including development of Risk Management Plan, creation of applicable Risk Analyses, and development of Final Risk Management Report.
- Have scientific knowledge pertinent to product development of medical devices
- Help completion of Post Market Surveillance for all Product Commercialization Process.
- Develops Quality Plans for new products. Researches and documents historical data (e.g. complaints, CAPAs, Service Data, Repair Data) for similar products/components. Ensures quality objectives are defined and measurable.
- Provide technical knowledge in the development of emerging technologies for medical devices. Participates and leads design review meetings for new products.
- Assist with product design and help to develop testing, repair, and reliability requirements for medical devices
- Key liaison between R&D project teams and Supplier Quality for qualification of new components/assemblies and suppliers. Works with Supplier Quality on Control plans, First Articles, PFMEAs, and process validations for new parts. Performs on-site auditing of suppliers, as appropriate.
- Reviews and approves all production release specifications and drawings. Ensures Critical to Quality characteristics, SPC dimensions, and inspection characteristics are included on specifications/prints.
- Prepare Biocompatibility test plans, review test protocols and ensure that the product is in compliance, with applicable requirements.
- Provides technical assistance to Manufacturing, Quality and Operations groups throughout the early production builds and launch. Support the effort through documentation and training as required.
- Coordinates with Quality Assurance and Manufacturing Engineering to ensure organizational readiness for new components and/or assemblies. Activities include ensuring drawings/specifications are clear, availability of correct tools/equipment for inspection/test, and qualification of measurement/test methods.
- Participates in all phases of product verification and validation. Works with Verification Engineering in preparing protocols/test methodologies, developing sample sizes, and establishing acceptance criteria. Reviews all test data, analysis, and final test reports.
- Reviews and approves all labeling (e.g. User Manuals, Repair Manuals, IFUs) developed for new products
- Bachelor of Science degree in an engineering field (i.e. Mechanical, Electrical, Biomedical, or other related field)
- Minimum of 5 years of design experience in a regulated industry with a Bachelor’s degree OR
- Minimum of 3 years of design experience in a regulated industry with a Master’s degree
- Experience in regulated design environments, such as medical device development, FDA, or ISO registered work experience
- Experience with Risk Management ISO 14971
- Experience with Quality Engineering, Product Development, or Design Verification engineering
- Experience in print and specification development and review
- Ability to deal effectively with all employees and external business contacts while conveying a positive, service oriented attitude.
- Ability to communicate effectively, both verbally and in writing, to technical and non-technical audiences.
- Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment.
- Complete understanding and wide application of technical principle, theories, and concepts in design assurance and product development
- Ability to provide creative and thorough technical solutions to a wide range of difficult problems.
- Ability to anticipate problems and recognize when to deviate from standard practices
- Independently determines and develops approaches to solutions
- Master’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or similar technical degree
- Experience with CE, UL/ETL/BSi
- Six Sigma related to the design and manufacturing of new products