Manufacturing Engineer

Actalent • Fridley, MN • 1h ago

Job Title: Process Development Engineer - Delivery Systems

Job Description

The Process Development Engineer - Delivery Systems develops and refines manufacturing processes for complex catheter-based delivery systems, focusing on post-design-freeze activities to ensure robust and scalable production of high-performance medical devices. This role involves tooling, fixture development, process characterization, and validation (IQ/OQ/PQ). The engineer will act as a technical subject matter expert, driving process innovation and execution through collaboration with cross-functional partners in Quality, Operations, and Program Management.

Responsibilities

Develop, optimize, and validate manufacturing processes for catheter-based delivery systems, including reflow, bonding, and molding.

Serve as a technical liaison between Product Development and Operations, ensuring smooth transition of designs into stable, validated manufacturing processes.

Lead DOE studies and data analysis using tools such as Minitab, and present detailed process development and validation plans.

Coordinate manpower, facility, and equipment for assigned projects, developing schedule milestones.

Assist in improving production controls, standard operating procedures, safety, quality control, and training.

Coordinate the manufacturing launch of new/revised products, establish goals, train team members, and evaluate results.

Design and develop custom tooling and fixtures to support cleanroom manufacturing.

Perform product/process analysis for capability (CPK/PPK), yield, and efficiency improvement using statistical and risk-based approaches.

Provide leadership and train less experienced engineers and technicians as needed.

Essential Skills

Bachelor's degree in a related field or equivalent work experience.

Minimum of 7 years of experience as an individual contributor in Product and Process development.

Hands-on experience with catheters, balloons, steerable sheaths, braiding, coiling, handles, and molding.

Demonstrated ability to develop medical device manufacturing processes from concept to production.

Experience with Design for Manufacturability (DFM), design control, and process validations (IQ/OQ/PQ).

Proficiency with SolidWorks and/or Mastercam.

Proficiency in MS Office and project management.

Additional Skills & Qualifications

Experience with medical device quality systems and product development phases.

Ability to handle multiple projects simultaneously.

Strong interpersonal skills and ability to work cross-functionally to drive results.

Work Environment

This role involves working independently within a growing team at a medical device contract manufacturer. The work environment includes cleanroom manufacturing settings, with a focus on process efficiency and reducing operator skill complexity. Shifts may vary, with possible hours from 12pm-10pm or 3:30pm-2am

Job Type & Location

This is a Contract to Hire position based out of Fridley, 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 Fridley,MN.

Application Deadline

This position is anticipated to close on Apr 24, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

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