Job Title: High- level Manufacturing EngineerJob DescriptionThe highManufacturing Engineer leads the development, optimization, and documentation of manufacturing processes for medical device products in a clean-room environment. This role focuses on translating product specifications into efficient production methods, driving continuous improvement initiatives, supporting cross-functional teams, and ensuring compliance with regulatory and quality standards. The engineer also mentors other engineers and technicians while managing multiple high-profile projects that enhance operational efficiency and product quality.Responsibilities
- Analyze product specifications and translate them into manufacturing processes that establish production rates, achieve expected quality levels, and ensure the reliability of finished products.
- Identify tooling-related issues, collaborate with tool makers to resolve problems, and ensure tools support robust and efficient production.
- Develop manufacturing methods for new and existing products, establish labor standards, and create accurate product cost information.
- Meticulously document all manufacturing process information and sequences within the document control system to maintain clear, controlled, and compliant records.
- Identify opportunities for improvement in existing processes and methods using data analysis and observation, then develop and implement enhancements as quickly as practical.
- Improve production rates and reduce scrap by identifying and implementing new equipment, improved processes, or optimized 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 maintain smooth manufacturing operations.
- Serve as an active member of the CAPA team, leading and supporting the implementation of permanent corrective actions to address root causes of issues.
- Participate in determining product DMR disposition plans and approvals in collaboration with the value stream (VS) team.
- Follow ISO standards, 21 CFR Part 11 and Part 820 requirements, and internal protocols to ensure regulatory and quality compliance.
- Execute design of experiments (DOE), lead problem-solving activities, perform FMEAs, and develop validations, control plans, and continuation engineering for products.
- Actively support Production, Engineering, and Quality departments with technical expertise and process improvements.
- Mentor Manufacturing Engineers and Technicians through hands-on experience, guidance, and educational opportunities.
- 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 timely delivery, alignment with business goals, and effective stakeholder communication.
Essential Skills
- Demonstrated experience in manufacturing engineering, with a focus on developing and optimizing production processes.
- Experience in lean manufacturing and continuous improvement methodologies, including the use of Lean Sigma tools.
- Ability to follow good manufacturing practices (GMP) and principles to provide engineering support and develop robust manufacturing processes.
- Experience applying engineering theory and principles to optimize value streams for specific products.
- Hands-on experience in a clean-room manufacturing environment, preferably within the medical device industry.
- Proficiency in conducting and analyzing design of experiments (DOE) for process optimization.
- Experience with problem solving, including root cause analysis and structured methodologies.
- Ability to perform and interpret failure modes and effects analyses (FMEAs) for risk assessment and mitigation.
- Experience in process validations, development of control plans, and continuation engineering for existing products.
- Familiarity with CAPA processes and the implementation of permanent corrective actions.
- Knowledge of DMR disposition processes and collaboration with cross-functional teams to determine product disposition.
- Understanding of ISO standards and regulatory requirements, including 21 CFR Part 11 and Part 820.
- Strong documentation skills and attention to detail for maintaining accurate and compliant process records.
- Ability to support and collaborate effectively with Production, Engineering, and Quality departments.
Additional Skills & Qualifications
- Experience in the medical device manufacturing industry.
- Ezperience in clean-room operations and associated process controls.
- Proven ability to mentor and develop Manufacturing Engineers and Technicians.
- Track record of developing strategies that improve operational efficiency and business performance.
- Demonstrated capability to manage multiple high-profile projects simultaneously.
- Commitment to fostering a culture of continuous improvement.
- Eligibility for and interest in participating in performance-based bonus programs, such as quarterly bonuses.
Work EnvironmentThis is an onsite role supporting in-house projects at a manufacturing facility, with little to no travel required. The Manufacturing Engineer spends the majority of their time on the production floor working closely with the manufacturing team of approximately twelve people and collaborating regularly with leadership and cross-functional partners. The environment includes clean-room operations and medical device manufacturing processes, with a strong focus on quality, safety, and regulatory compliance. The culture emphasizes continuous improvement, cross-functional support, and performance-based recognition, including participation in a quarterly bonus Job Type & LocationThis is a Permanent position based out of Delano, MN. Pay and BenefitsThe pay range for this position is $80000.00 - $120000.00/yr. 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.Excellent company benefits, grow opportunities, and paid time off. Job Type & LocationThis is a Permanent position based out of Delano, MN. Application DeadlineThis position is anticipated to close on Nov 18, 2026. Workplace TypeThis is a fully onsite position in Delano,MN.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.
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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):
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