Senior Manufacturing Engineer

About the role

Lead 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.

Requirements

• 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.

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.

Pay

The pay range for this position is $45.00 - $60.00 per hour.

Benefits

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, and vision insurance
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short-term and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation, or Sick Leave)

Schedule

This is a Contract to Hire, fully onsite position based in Delano, MN.