Job 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 for new products.
- Participates 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.
- Helps 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.
- Participates in design review meetings for new products.
- 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.
- 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 labelling (e.g. User Manuals, Repair Manuals, IFUs) developed for new products
- Participates in any and all reasonable work activities as may be deemed suitable and assigned by management
- Conform to, support and enforce all Company policies and procedures
- Performs other duties/responsibilities as assigned by management
- Bachelor of Science degree in an engineering field (i.e. Mechanical, Electrical, Biomedical, or other related field)
- Minimum of 3 years of design experience in a regulated industry with a Bachelor’s degree OR
- Minimum of 1 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
- 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.