Job Description
The lead Manufacturing Engineer leads the development, optimization, and support of manufacturing processes to ensure high-quality, reliable, and cost-effective production in a regulated, clean-room environment. This role focuses on translating product specifications into robust manufacturing methods, driving continuous improvement, supporting cross-functional teams, and mentoring other engineers and technicians while managing multiple high-profile projects.
Responsibilities
Analyze product specifications and translate them into efficient manufacturing processes that establish production rates, achieve expected quality levels, and ensure the reliability of finished products.
Identify tooling-related issues and collaborate closely with tool makers to resolve problems and improve tool performance.
Develop manufacturing methods for new and existing products, including establishing labor standards and generating accurate product cost information.
Meticulously document all manufacturing process information, sequences, and changes within the document control system to maintain full traceability and compliance.
Identify opportunities for improvement in existing processes and methods using data analysis and direct observation, then develop and implement improvements as quickly as practical.
Increase production rates and reduce scrap by identifying, evaluating, and implementing new or improved equipment, processes, or human factors methods.
Assist production teams in troubleshooting issues with individual components and processes, and implement solutions that support on-time customer deliveries and superior product quality.
Review production schedules and engineering specifications to resolve production problems and ensure alignment between design intent and manufacturing capabilities.
Act as an active member of the CAPA team, implementing permanent corrective actions to address root causes of quality and process issues.
Participate in determining product DMR disposition plans, collaborating with the value stream team to define and approve appropriate actions.
Follow ISO standards, 21 CFR Part 11 and Part 820, and internal protocols to ensure regulatory compliance and robust quality systems.
Plan and execute Design of Experiments (DOEs), perform structured problem solving, conduct FMEAs, support validations, and develop control plans for manufacturing processes.
Provide continuation engineering support for products to maintain and improve performance, quality, and manufacturability over the product lifecycle.
Actively support Production, Engineering, and Quality departments by providing technical guidance, process expertise, and hands-on support.
Mentor Manufacturing Engineers and Technicians, sharing knowledge, experience, and best practices to develop their skills and capabilities.
Develop ideas and strategies to improve operational efficiency, add value, enhance business performance, and foster a culture of continuous improvement.
Successfully manage multiple high-profile projects simultaneously, ensuring clear priorities, effective communication, and timely completion.
Apply Lean manufacturing and Lean Sigma tools to optimize value streams and eliminate waste in manufacturing operations.
Adhere to and promote Good Manufacturing Practices (GMP) and principles in all engineering and production support activities.
Essential Skills
Strong experience in manufacturing engineering with responsibility for developing and supporting robust manufacturing processes.
Proven ability to apply Lean manufacturing principles and Lean Sigma tools to optimize value streams and drive continuous improvement.
Hands-on experience working in a clean-room manufacturing environment.
Deep understanding and practical application of Good Manufacturing Practices (GMP) in a regulated setting.
Experience in medical device manufacturing or similarly regulated industries.
Demonstrated capability in process development, including establishing production rates, labor standards, and product cost information.
Proficiency in identifying and resolving tooling-related issues in collaboration with tool makers.
Strong skills in structured problem solving, including execution of DOEs, FMEAs, validations, and development of control plans.
Ability to meticulously document manufacturing processes and maintain accurate records within a controlled document system.
Familiarity with ISO standards and regulatory requirements, including 21 CFR Part 11 and Part 820.
Proven track record of supporting production, engineering, and quality teams in troubleshooting and resolving manufacturing issues.
Ability to manage multiple high-profile projects simultaneously with strong organizational and prioritization skills.
Effective communication and collaboration skills for working with cross-functional teams.
Demonstrated ability to mentor and guide engineers and technicians.
Additional Skills & Qualifications
Experience leading or actively participating in CAPA activities and implementing permanent corrective actions.
Experience participating in DMR disposition decisions as part of a cross-functional value stream team.
Work history in continuation engineering for existing products, focusing on ongoing improvements to quality, cost, and manufacturability.
Experience developing and implementing strategies that improve operational efficiency and overall business performance.
Strong analytical skills and the ability to use data and observation to identify process improvement opportunities.
Experience in human factors considerations to enhance productivity and reduce scrap.
Interest in and commitment to fostering a culture of continuous improvement.
Eligibility for participation in a bonus program, reflecting performance and company results (as applicable to this role).
Job Type & Location
This is a Permanent position based out of Minnetonka, MN.
Pay and Benefits
The pay range for this position is $45.00 - $60.00/hr.
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 Minnetonka,MN.
Application Deadline
This position is anticipated to close on Aug 19, 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 adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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 condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
