Staff Medical Device Engineer

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP)

Safety Standards, Office Job Description 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.

Key Responsibilities:

Documentation and Compliance:

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

Process Improvement:

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

FATs/SATs:

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.

Vendor Management:

Work closely with vendors to ensure timely projects and training for equipment. Detailed design review for the assembly and manufacture of a product

Customers:

Support product feasibility assessments. 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

Qualifications:

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. Experience working with Device vendors and OEMS Strong experience working with Autoinjectors 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). Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills. Ability to work collaboratively in a team environment. Experience with FATs/SATs and vendor management is highly desirable.

Working Conditions:

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.