Engineer

Job Title: Process Development Engineer (Contractor)

Job Description

This contract Process Development Engineer role focuses on developing, validating, and improving manufacturing processes for catheter delivery systems within the medical device industry. The engineer will lead process validations, support equipment design and implementation, and create robust technical documentation to ensure safe, efficient, and compliant production. The position is onsite and highly collaborative, working closely with cross-functional teams to drive continuous improvement in product quality and process performance.

Responsibilities

• Author and execute process validations, including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Product Performance Qualification (PPQ).

• Lead and support process development activities, including defining requirements, developing process parameters, and implementing robust manufacturing processes for catheter delivery systems.

• Specify, acquire, and implement process development equipment, ensuring that equipment meets technical requirements and supports efficient and compliant production.

• Analyze current equipment and processes for suitability, identify gaps, and develop detailed plans and recommendations for improvements in quality, efficiency, and safety.

• Plan and execute Design of Experiments (DOE) to characterize processes, optimize parameters, and support continuous improvement initiatives.

• Perform process characterization and data analysis, interpret results, and present findings and recommendations to equipment and cross-functional teams.

• Create, revise, and maintain manufacturing documents, including manufacturing procedures, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and technical reports.

• Apply engineering principles, theories, concepts, practices, and techniques to analyze and solve problems related to materials, equipment, and processes.

• Collaborate with other engineers and technicians to develop solutions and improvements in materials, tooling, equipment, and processes as needed.

• Participate in cross-functional teams to support continual improvement, safety initiatives, and regulatory compliance.

• Provide training and process expertise for product processing in specific areas such as process development, tooling development, and validation.

• Interact cross-functionally with internal and external stakeholders, including R&D, Quality Engineering, Manufacturing Engineering, and Operations, to ensure alignment and successful implementation of process changes.

• Support assembly operations, UV curing, and mechanical assembly processes related to catheter delivery systems.

• Prepare and deliver data presentations and technical updates to equipment teams and other stakeholders.

Essential Skills

• 13 years of engineering experience, preferably in process development or related roles.

• Bachelors degree in Mechanical Engineering or Biomedical Engineering, or a closely related engineering discipline.

• Required experience in the medical device industry, which may include internships.

• Strong understanding of engineering principles, theories, concepts, practices, and techniques.

• Hands-on experience authoring and executing process validations, including IQ, OQ, and PQ.

• Ability to perform Design of Experiments (DOE) and analyze experimental data to support process characterization and optimization.

• Proficiency in technical writing, including manufacturing procedures, technical reports, and SOP documentation.

• Demonstrated ability to analyze and solve problems using basic engineering principles and data-driven approaches.

• Experience collaborating with cross-functional teams such as R&D, Quality Engineering, Manufacturing Engineering, and Operations.

• Strong communication skills for presenting data, documenting findings, and training others on processes and procedures.

Additional Skills & Qualifications

• Bachelors degree in Mechanical Engineering or Biomedical Engineering preferred; candidates with Electrical or Software Engineering degrees may be considered if they are a strong fit.

• Open to candidates with a masters degree in a relevant engineering field.

• CAD software experience is highly desirable for equipment design and development.

• Experience with statistical analysis tools, with Minitab exposure considered a plus; academic experience with statistics is acceptable.

• Experience with catheter delivery systems or similar medical device products is preferred.

• Exposure to assembly operations, UV curing, and mechanical assembly processes is beneficial.

• Familiarity with quality management and documentation systems (such as TrackWise, electronic lab notebooks, or MasterControl) is helpful but not required.

• R&D and product development profile is welcomed but not mandatory.

• Ability to work independently while contributing effectively within cross-functional teams.

• Strong attention to detail and commitment to developing safe, efficient, and compliant processes.

Work Environment

This role is based onsite five days per week in a medical device manufacturing and development environment, with a typical schedule of approximately 8:00 AM to 5:00 PM and some flexibility in hours, provided consistency is maintained. The work focuses on catheter delivery systems and involves hands-on interaction with process development equipment, assembly operations, UV curing, and mechanical assembly processes. The engineer will work closely with R&D, Quality Engineering, Manufacturing Engineering, and Operations in a collaborative, team-oriented setting that emphasizes continuous improvement, safety, and regulatory compliance. Virtual interviews are available for non-local candidates, and individuals willing to relocate to Minnesota are encouraged to apply. The environment supports professional growth through exposure to advanced process validation, data analysis, and cross-functional project work.

Job Type & Location

This is a Contract position based out of Minnetonka, MN.

Pay and Benefits

The pay range for this position is $40.00 - $40.00/hr.

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.

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)

Job Type & Location

This is a Contract position based out of Minnetonka, MN.

Application Deadline

This position is anticipated to close on Nov 12, 2026.

Workplace Type

This is a fully onsite position in Minnetonka,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.

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 [email protected] 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.