Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Summary: The Staff Medical Device Engineer will be responsible for developing and maintaining Standard Operating Procedures (SOPs), On-the-Job Training (OJT) documents, and line templates. This role involves ensuring compliance with regulatory standards, optimizing manufacturing processes, and collaborating with vendors.
The ideal candidate will have a strong background in pharmaceutical engineering, process improvements, and experience with Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs). We are essentially looking for a device-centric autoinjector subject matter expert.
- Ensure all documentation is accurate, up-to-date, and accessible to relevant personnel.
- Compile and create documentation in accordance with relevant regulatory requirements.
- Manage all post-submission Design History File (DHF) updates in collaboration with Development device teams
- Support the creation and maintenance of product Design Master Records (DMRs) post-submission
- Identify and implement process improvements to enhance efficiency, quality, and safety in manufacturing operations.
- Conduct root cause analysis and implement corrective actions for process deviations.
- Collaborate with cross-functional teams to optimize production processes and reduce waste.
- Responble for process characterization and defining the specification(s) for the critical process parameters (CPPs) to be used for the device assembly process
- Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) to ensure equipment and systems meet specified requirements.
- Coordinate with vendors and internal teams to address any issues identified during FATs/SATs.
- Document and report test results, ensuring all acceptance criteria are met.
- Work closely with vendors to ensure timely projects and training for equipment.
- Detailed design review for the assembly and manufacture of a product
- Coordinate all transfer activities from development to operational QC for device testing
- Manage qualification and validation activities associated with exhibit, submission and commercial launch batch manufacturing
- Conduct feasibility assessments and determine the manufacturing strategy for device projects with the Steriles technologies
- Graduate level degree (Master's) in Pharmaceutical Engineering, Chemical Engineering, Physics, or similar field highly preferred.
- 8+ years of operations experience in a pharmaceutical manufacturing environment.
- Knowledge of the regulatory requirements for devices and combination products with the US and EU, including the compilation of Design History Files and Design Master records.
- Knowledge of Device Quality Management Systems in accordance with ISO13485 and 21CFR820
- Experience of managing Device Development Projects, ideally from concept to launch
- Understanding of device and drug/device combination regulatory requirements
- Understanding of device design and assembly including tool development and manufacturing processes
- Experience with process improvement methodologies (e.g., Lean, Six Sigma).
- Experience with FATs/SATs and vendor management is highly desirable.
- This position may require occasional travel to vendor sites and manufacturing facilities.
- Work in a fast-paced, dynamic environment with changing priorities.
We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team.