Sr. Manufacturing Engineer
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Job Location:
Plymouth, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Sr. Manufacturing Engineer
Location: Plymouth MN 55442
Duration: 6 months contract with possible extension
Shift/Schedule: Mon to Fri
Job Description:
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 Youll 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
Bachelors 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.
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 Youll 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
Bachelors 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.
