Jobs

Description

8:30 am  5:30 pm

• Candidate must have bachelors degree in engineering from US institution, with 3-4+ years of experience in medical device manufacturing.
• Candidate must be able to provide sound examples of changes / impact they led/implemented with details on what, why and how.
• Experience in yield improvement and productivity improvement are preferred.

Job Description:

• Client’s Electrophysiology business is seeking a high caliber, motivated, and self driven leader to join the New Product Introduction (NPI) – Operations team at our Plymouth location. This role plays a critical part in rapidly improving manufacturing performance for recently launched catheter products and ensuring successful transfer from design to full scale manufacturing.
• The Senior Manufacturing Engineer will operate as a strong individual contributor while also leading cross functional projects involving Operations, Supply Chain, Quality, and Development teams.
• This position is responsible for yield improvement, process optimization, and technical leadership throughout product launch, stabilization, and ramp up.

What You’ll Work On

Manufacturing & Yield Improvement

• Lead yield improvement initiatives across catheter manufacturing processes, including reflow, stringing, assembly, soldering, bonding, and packaging.
• Apply structured problem solving methodologies (e.g., DMAIC, Root Cause Analysis, A3) to resolve manufacturing issues and improve process capability and robustness.
• Analyze manufacturing data to identify trends, process variation, and opportunities for cost, quality, and throughput improvements.

• Technical Leadership & Execution
• Serve as a technical subject matter expert in catheter manufacturing processes, materials, and equipment.
• Coordinate the design, procurement, build, and debugging of tooling, machinery, and test equipment.
• Support new product introductions (NPI), process scale up, and technology transfer from R&D to manufacturing.

Cross Functional Collaboration

• Work collaboratively with Quality, Process Development, R&D, Supply Chain, Operations, and Regulatory teams to ensure successful launches and sustained performance.
• Ensure manufacturing processes comply with FDA, ISO 13485, GMP, and Client quality system requirements.

Coaching & Mentorship

• Provide technical guidance during investigations, process development, and continuous improvement activities.
• Mentor and coach junior engineers and technicians to strengthen problem solving skills and technical capability.
• Lead cross functional project teams and drive accountability toward key deliverables and timelines.

Individual should:

• Innovative, resourceful, and able to work with minimal direction.
• Highly organized with strong attention to detail.
• Data driven, results oriented decision maker.
• Ability to multitask and prioritize effectively in fast paced manufacturing environments.
• Strong communicator who works effectively across functions.
• Quick learner with a passion for continuous improvement and technical excellence.

Required Qualifications

• Bachelor’s degree in Mechanical, Chemical, Biomedical, or other relevant engineering discipline, or equivalent technical experience.
• Minimum 5 years of manufacturing engineering experience, with background in manufacturing or process development.
• Strong analytical, problem solving, and project management skills.
• Demonstrated leadership capability within team based environments.
• Ability to lead and motivate peers, drive change, and approach problems creatively and pragmatically.
• Ability to travel up to 25%, including international travel.

Preferred Qualifications

• Medical device manufacturing experience (required).
• Previous experience supporting NPI, pilot builds, and ramp to production environments.