Staff Medical Device Engineer

Thermo Fisher Scientific•Greenville, NC

About The Position

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.

Requirements

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.

Nice To Haves

Experience with FATs/SATs and vendor management is highly desirable.

Responsibilities

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
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