We’re looking to expand the process development engineering department of a fast-growing medical device company and have roles at multiple seniorities.
Responsibilities:
- Develop processes for medical devices within an ISO 13485 environment
- Create, review, and maintain documentation (DHRs, work instructions, procedures)
- Serve as a technical liaison to customers, providing engineering expertise
- Lead validation activities and execute test plans with strong technical rigor
- Analyze data using statistical methods and generate reports
- Support NPI by establishing robust, repeatable, and scalable processes
- Drive process development from feasibility through transfer to manufacturing
- Design and run DOE studies to optimize performance
- Support production during transfer, ramp-up, and steady-state manufacturing
- Lead continuous improvement using Lean/Six Sigma methodologies
Qualifications:
- Bachelor’s degree in Engineering (or related field)
- 2-10 years in process, manufacturing, or development engineering
- Strong knowledge of validation, process characterization, and statistics
- Experience with DOE and root cause tools
- Ability to read technical drawings and process flows
- Strong problem-solving, communication, and cross-functional leadership skills
- Knowledge of ISO, FDA, or GMP standards