Work Schedule

Environmental Conditions

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.