Technical Lead, Manufacturing Line, NPI Medical Device

Job Title: Technical Lead, Manufacturing Line, NPI Medical Device Job Description
This role provides technical leadership and operational oversight for commercial medical device manufacturing operations and new product introduction activities. The Technical Lead serves as the primary engineering owner for manufacturing line performance, process validations, equipment reliability, product quality, capacity expansion, automation initiatives, and continuous improvement. The position partners closely with Operations, Quality, Supply Chain, Regulatory Affairs, R&D, and Manufacturing Engineering to support production goals, manufacturing scale-up, product launches, and operational excellence initiatives, while mentoring engineers and driving strategic manufacturing improvements.
Responsibilities
- Serve as the primary technical owner of the manufacturing line, ensuring stable, efficient, and compliant operations.
- Lead process validations and equipment qualifications to ensure robust, capable, and compliant manufacturing processes.
- Manage manufacturing change implementation, including change control activities and documentation.
- Drive the technical strategy that supports safety, quality, delivery, and manufacturing continuity across the line.
- Support new product introductions by leading process development, technology transfer, line readiness, and production scale-up activities.
- Provide technical leadership for capital equipment projects, automation initiatives, and facility upgrades.
- Design and optimize manufacturing processes, line layouts, equipment installations, and material handling systems to improve flow and efficiency.
- Develop and improve manufacturing processes using statistical process control (SPC) methodologies.
- Investigate equipment and process issues, perform root cause analysis, and implement corrective and preventive actions to enhance product quality and operational performance.
- Analyze manufacturing metrics such as yield, capacity, labor utilization, and overall equipment effectiveness (OEE) to identify and drive improvement opportunities.
- Identify technical risks associated with processes, equipment, and new products, and develop mitigation strategies.
- Partner with Operations and Quality teams to ensure compliance with FDA Quality System Regulations and applicable ISO requirements.
- Serve as the primary escalation point for manufacturing performance issues and product launch support needs.
- Mentor and guide manufacturing engineers, process engineers, and cross-functional team members, fostering technical development and best practices.
- Lead cross-functional technical initiatives that support manufacturing strategy, continuous improvement, and long-term operational excellence.
Essential Skills
- Bachelor's degree in Engineering or a related technical discipline.
- Minimum 7 years of relevant manufacturing engineering experience; an advanced degree with 5+ years of experience may be considered.
- Proven experience supporting medical device manufacturing operations.
- Strong background in process validation, including protocol development, execution, and reporting.
- Demonstrated experience in equipment qualification and manufacturing change control.
- Hands-on experience with semi-automated manufacturing equipment and assembly systems.
- Knowledge of PLC-controlled equipment and machine interfaces.
- Experience with vision inspection systems and automated manufacturing equipment.
- Strong understanding of OEE analysis, capacity planning, yield improvement, and scrap reduction.
- Proficiency in root cause analysis methodologies and structured problem-solving.
- Ability to lead technical decision-making, project execution, and cross-functional initiatives.
- Experience mentoring engineers and providing technical leadership in a manufacturing environment.
- Manufacturing engineering experience in a regulated environment, with familiarity in FDA Quality System Regulations and ISO requirements.
- Experience with SAP or similar enterprise systems for manufacturing or operations.
- Demonstrated capability in continuous improvement within manufacturing operations.
Additional Skills & Qualifications
- Experience with new product introduction (NPI) and manufacturing scale-up activities.
- background in medical device manufacturing, including understanding of regulatory and quality expectations.
- Experience with automation projects, including PLC systems and vision inspection systems integration.
- Exposure to capital equipment planning, selection, installation, and validation.
- Experience with statistical process control (SPC) and data-driven process optimization.
- Demonstrated success in yield improvement, capacity planning, and scrap reduction initiatives.
- Technical project leadership experience, including managing timelines, risks, and cross-functional coordination.
- Experience with technology transfer from R&D or pilot lines into full-scale manufacturing.
- Familiarity with manufacturing strategy development and implementation.
- Comfort working with large-scale enterprise systems such as SAP for production and materials management.
Work Environment
The role is based within a large medical device manufacturing campus that includes multiple sites and an extensive production footprint. The Technical Lead works closely with manufacturing lines that are being newly established or scaled up, as well as in engineering office areas and cubicles for design, analysis, and documentation activities. The environment combines hands-on interaction with semi-automated and automated equipment on the production floor with office-based collaboration, planning, and data review. You will routinely engage with cross-functional teams, modern manufacturing technologies, and capital equipment in a setting focused on high quality, operational excellence, and continuous improvement.
Job Type & Location
This is a Contract to Hire position based out of Northridge, CA.
Pay and Benefits
The pay range for this position is $103.33 - $105.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Northridge,CA.
Application Deadline
This position is anticipated to close on Sep 30, 2026. About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without
regard to race, sex, age, color, religion, national origin, veteran status, disability,
sexual orientation, gender identity, genetic information or any characteristic protected
by law.

If you would like to request a reasonable accommodation, such as the modification or
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San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
city and county of San Francisco, we will consider for employment qualified applicants
with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
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shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
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