Manufacturing Manager

Manufacturing Manager -

Medical Devices Job Description:

The Manufacturing Manager leads all production floor operations in a medical device manufacturing facility, ensuring the consistent, compliant, and efficient manufacture of high-quality endoscopic devices. This role serves as a critical bridge between engineering, operations, quality, and supply chain, driving performance against business, regulatory, and operational goals in a highly regulated environment.

Responsibilities:

+ Oversee day-to-day manufacturing operations for endoscope production lines, including assembly, testing, sterilization, packaging, and final inspection. + Lead, mentor, and develop supervisors, technicians, and operators by setting clear performance metrics and driving continuous improvement in productivity, yield, and quality. + Collaborate closely with engineering and R D teams to transfer new endoscope designs into production, optimize manufacturability, improve processes, and scale up production volumes. + Ensure full compliance with applicable regulatory, quality, and safety standards, including 21 CFR 820, EU MDR, and other relevant medical device regulations. + Establish, monitor, and report on key performance indicators such as throughput, yield, scrap rate, cycle time, and on-time delivery, and drive corrective actions when targets are not met. + Work with supply chain and procurement teams to ensure timely availability of materials, components, and subassemblies to support production schedules and minimize downtime. + Implement Lean and Six Sigma methodologies to reduce waste, minimize nonconformances, and strengthen process robustness across the manufacturing operation. + Coordinate with quality assurance and quality control to address deviations, CAPAs, root cause investigations, and corrective and preventive actions, ensuring sustainable solutions. + Manage the operations budget, including cost control, resource allocation, and capital investments for manufacturing improvements and capacity expansion. + Ensure documentation integrity for work instructions, batch records, change control documentation, and other controlled documents in accordance with good documentation practices. + Interface confidently with external auditors and regulatory inspectors, ensuring manufacturing practices, records, and systems can withstand audits, supplier assessments, and compliance reviews. + Champion a culture of safety, quality, and continuous improvement on the production floor, fostering strong cross-functional collaboration and clear communication.

Essential Skills:

+ Bachelor's degree in engineering, manufacturing, mechanical, biomedical engineering, or a related technical discipline. + Minimum 5 years of experience in medical device manufacturing, including at least 3 years in a supervisory or management role overseeing production or operations in a regulated environment. + Hands-on knowledge of medical device quality systems and regulatory requirements, including 21 CFR 820, design controls, and risk management standards such as ISO-based frameworks. + Proven leadership, communication, and team-building skills, with a track record of developing talent and driving high performance in manufacturing teams. + Experience implementing continuous improvement initiatives, lean manufacturing principles, statistical process control (SPC), and structured root cause problem solving. + Ability to manage change control, process validation, equipment qualification, and detailed process documentation in a regulated setting. + Strong analytical skills with experience using metrics, data analysis, process monitoring, and productivity reporting to guide decisions. + Proficiency with manufacturing systems, including ERP/MRP platforms, process control software, and standard engineering tools used in production environments. + Technical experience in medical device, manufacturing, or electronics, including familiarity with mechanical engineering concepts and PCB-related manufacturing. + Experience supervising or managing teams in a manufacturing or electronics production environment.

Additional Skills & Qualifications:

+ Experience working specifically with endoscopic devices, optical assemblies, or similar minimally invasive and precision medical devices. + Certification or formal training in Lean or Six Sigma methodologies, such as Green Belt or Black Belt credentials. + Experience leading multi-disciplinary teams and driving cross-functional collaboration across R D, quality, supply chain, and operations. + Experience scaling products from prototype to full-scale production while systematically reducing cost over time. + Experience in supplier qualification, vendor management, contract manufacturing, or outsourcing in a regulated industry. + Experience in electrical and mechanical design considerations for medical devices and related manufacturing processes. + Familiarity with medical device development within a regulated framework and the use of advanced technologies in medical device engineering. + Ability to thrive in a fast-paced environment with dynamic priorities and contribute to innovative, practical solutions. Job Type & Location This is a Contract to Hire position based out of Minneapolis, MN. Pay and Benefits The pay range for this position is $45.00 - $65.00/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 Minneapolis,MN.

Application Deadline This position is anticipated to close on May 29, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. 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.