Senior Manufacturing Engineer

Job Title: Manufacturing EngineerJob DescriptionThe higher level Manufacturing Engineer plays a key role in developing, optimizing, and supporting manufacturing processes for medical device products in a clean-room environment. This position focuses on translating product specifications into robust, efficient production methods, driving continuous improvement, and ensuring compliance with relevant regulations and quality standards. The role actively supports Production, Engineering, and Quality departments while mentoring engineers and technicians and successfully managing multiple high-profile projects.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, communicate effectively with tool makers, and collaborate to resolve these issues promptly.
• 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 accurate and compliant records.
• Identify opportunities for improvement in existing processes and methods using data analysis or direct observation, then develop and implement enhancements as quickly as practical.
• Improve production rates and reduce scrap by identifying and implementing new or better 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 delivery and superior product quality.
• Review production schedules and engineering specifications to resolve production problems and maintain efficient workflow.
• Serve as an active member of the CAPA team, implementing permanent corrective actions to address nonconformances and systemic issues.
• Participate in determining product DMR disposition plans and approvals in collaboration with the value stream team.
• Follow ISO standards, 21 CFR Part 11 and Part 820, and internal protocols to ensure regulatory and quality compliance in all manufacturing activities.
• Execute design of experiments (DOE), perform problem solving, conduct FMEA, lead validations, and develop control plans to support continuation engineering for products.
• Actively support Production, Engineering, and Quality departments by providing manufacturing engineering expertise and guidance.
• Mentor Manufacturing Engineers and Technicians through hands-on experiences and educational opportunities as they arise.
• Develop ideas and strategies to improve operational efficiency, add value, and enhance business performance while fostering a culture of continuous improvement.
• Successfully manage multiple high-profile projects simultaneously, ensuring milestones are met and objectives are achieved.

Essential Skills

• Strong manufacturing engineering experience with the ability to develop and optimize manufacturing processes for medical device products.
• Hands-on experience with lean manufacturing principles and Lean Sigma tools to optimize value streams and drive continuous improvement.
• Proficiency in following good manufacturing practices (GMP) and applying engineering theory and principles to develop robust manufacturing operations in a clean-room environment.
• Demonstrated ability to analyze product specifications and translate them into efficient, reliable manufacturing processes.
• Experience identifying and resolving tooling-related issues in collaboration with tool makers.
• Ability to establish labor standards and develop accurate product cost information.
• Strong documentation skills, with meticulous attention to detail in recording manufacturing process information and sequences in a controlled system.
• Proven capability to identify process improvement opportunities using data or observation and to implement improvements effectively.
• Experience troubleshooting production problems with components and processes to support delivery schedules and quality targets.
• Working knowledge of ISO standards and regulatory requirements under 21 CFR Part 11 and Part 820.
• Experience executing DOE, FMEA, validations, and developing control plans for manufacturing processes.
• Ability to actively support and collaborate with Production, Engineering, and Quality departments.
• Capability to manage multiple high-profile projects simultaneously while maintaining quality and timelines.
• Strong problem-solving skills and a continuous improvement mindset.

Additional Skills & Qualifications

• Experience in medical device manufacturing environments, particularly in clean-room operations.
• Experience in continuous improvement initiatives focused on operational efficiency and business performance.
• Experience mentoring Manufacturing Engineers and Technicians and supporting their professional development.
• Familiarity with CAPA processes and DMR disposition activities within a regulated manufacturing environment.
• Comfort working with value stream teams to optimize product flow and performance.
• Strong communication and collaboration skills to work effectively with cross-functional teams.
• Ability to develop strategies that support a culture of continuous improvement across manufacturing operations.

Work EnvironmentThis is an onsite position with little to no travel, primarily supporting in-house projects at a manufacturing site. The higher level Manufacturing Engineer spends the majority of their time on the production floor, working closely with the manufacturing team of approximately 12 people and collaborating directly with leadership. The environment includes clean-room operations and adherence to GMP, ISO standards, and 21 CFR Part 11 and Part 820 regulations. The role is highly interactive, involving frequent engagement with Production, Engineering, and Quality departments. The organization offers a quarterly bonus program, reflecting its commitment to recognizing performance and contributions, and promotes a culture of continuous improvement and collaboration. 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.Medical + prescription insurance Dental + vision HSA/FSA options 401(k) with up to 4% company match Company-paid life insurance Company-paid short- and long-term disability Paid parental leave Mental health/wellness resources Employee discounts + EAP Optional accident, critical illness, and hospital coverage Job Type & LocationThis is a Permanent position based out of Delano, MN. Application DeadlineThis position is anticipated to close on Nov 13, 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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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.

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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.