Senior Manufacturing Engineer

Senior Manufacturing Engineer

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 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.

Candidate must have 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.

Notes:
8:30 am - 5:30 pm

VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.