Medical Device Manufacturing

Senior-level engineering position for manufacturing engineering, for highly experienced engineers with multiple years of relevant experience in the medical device industry.

The senior engineer provides technical guidance and support to other engineers, while also performing complex engineering and administrative tasks. They also maintain a high level of awareness of current industry trends & best practices and propose new products / projects for implementation. Projects supported in this role can span from capacity expansion, equipment end of life replacement, yield improvement, technology change implementation, quality improvement and lean transformation initiatives. This role will collaborate with the various crossfunctional teams inside and outside of the plant including but not limited to quality, regulatory, R&D, PD, operations, technicians, and external vendors/consultants. Engineers at this level work under general direction from department leadership, and their work is typically reviewed upon completion, or at major project milestones.

Essential Duties and Responsibilities:

• Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for new product introductions through frequent interaction with R&D, PD, quality engineering, and operations using project management, design for manufacturability (DFM), and lean methodologies.

• Work with manufacturing engineering team on studies to characterize process inputs to drive development of critical manufacturing/process specifications that are both robust and meet quality expectations. Use appropriate statistical support and Design of Experiments (DOE).

• Collaborate cross functionally on complex projects requiring innovative and original solutions.

• Develop and maintain detailed project plans, timelines, resource allocation schedules and report on project progress to all stakeholders. Develop and support business cases.

• Participate on the planning, execution, and monitoring of department goals to ensure alignment with organizational objectives.

• Support development of departmental budgets.

• Lead the exploration and development of new process technologies that may be incorporated into new product development projects or existing manufacturing lines.

• Lead new product transfers by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality, cost effective products with optimized yields.

• Identify equipment and fixture needs within manufacturing operations.

• Apply appropriate technical skills and tools, such as DOE, SPC, hypothesis testing, capability studies, Gemba Walks, and lean manufacturing tools, to perform in depth analysis, determine root cause, and identify corrective actions.

• Develop process specifications which ensure user needs are met.

• Collaborate with cross-functional team to identify process improvement opportunities.

• Identify process improvement opportunities including new fixturing, equipment, and inspection solutions.

• Generate required documentation in support of manufacturing products and processes. These include engineering protocols/reports (TQ/TMV/IQ/OQ/PQ), PFMEAs and manufacturing instructions.

• Performs other duties as assigned.

Required Job Qualifications:

• Bachelor’s Degree or higher in any engineering discipline (preferably Mechanical, Industrial, or Biomedical).

• 7+ years of experience required.

• Minimum of 5 years related experience in an FDA/GMP regulated industry.

• Demonstrated problem-solving and critical thinking experience.

• Solid oral and written communication skills, including presentation skills.

• Solid interpersonal skills and ability to work in a cross-functional team environment.

• Solid understanding of statistical techniques and analysis.

• Project management experience.

• Proficient in CAD, Minitab, Excel, Word and PowerPoint.

• High attention to detail.

Preferred Job Qualifications:

• Six Sigma or Lean Six Sigma green/yellow belt.

• Experience with ERP.

• Experience with Smartsheet.

• Supervisory experience.

• OEE experience.

• Process improvements experience.

Physical / Mental Demands:

• The job is performed indoors in a variety of settings including office, manufacturing floor and warehouse with no abnormal hazards or risks. Protective safety clothing may occasionally be required including appropriate dress code: no makeup or jewelry, shoe coverings, gloves, hair net, and lab coat as needed.

• Work may require weekend and evening work.

• Work may require travel.

• Physical activity includes sitting, walking, standing, bending, squatting, reaching above shoulders and lifting up to 40 pounds.

• Work under stress in a fast-paced environment.

• Must be alert, able to concentrate, and use good judgment.

IMI specializes in tamper-evident technologies that help prevent drug diversion and misuse. Our solutions are essential to hospital and pharmacy drug security programs.