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- Evaluate mechanical product design and identify potential design quality issues and drive technical decisions.
- Lead and support DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating and resolving gaps.
- Lead CAPA/NCR/SCAR/complaint investigations and reports
- Supports and ensures the establishment of objective and measurable product requirements.
- Support engineering print specification definitions, development, and changes
- Lead preparation and maintenance of risk management files from product conception through post market surveillance
- Develop and maintain product release testing plans, associated test methods and procedures.
- Support design test and inspection method development and validation
- Support design verification/validation and reliability study execution
- Support contract manufacturing activities including Process Development, Process Validation (IQ/OQ/PQ), and Nonconformance Resolution
- Identifies and leads continuous improvement projects and quality systems improvements.
- BS degree in an engineering or physical/life science field with a minimum of 5 years relevant experience within the medical device industry or related function (a combination of education and experience may be considered)
- Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
- Good statistical data analysis skills
- Background in manufacturing processes for drug-device combination products related to development and commercial programs.
- Excellent verbal and written communication skills
- Ability to collaborate with internal customers, 3rd-party partners, and CMOs.
- Hybrid work flexibility
- A collaborative, innovative team that works as one to amplify your impact on your career, the work you do and patients' lives.