Job Title: Process Development Engineer
Job Description

Develop and execute plans for major process-related segments of complex product development projects. Compile and analyze process performance data to establish process design and specifications for newly designed or modified products. Plan and validate equipment and processes of newly designed products to meet internal and external requirements. Execute process development-related activities on projects and review progress to recommend appropriate revisions. Lead in the application and advancement of technologies developed.

ResponsibilitiesOversee process design, development, characterization, and validation for products in development.Work closely with R&D teams, customers, and leadership to define process specifications and performance requirements.Perform engineering and technical work involved in planning, organizing, and coordinating detailed information required to develop new products from concept to final product realization.Develop and manage strategies to bring processes from feasibility to launch.Contribute to early development phases and be the voice of design for manufacturability.Identify suitable processes and equipment early in development and ensure robust manufacturable product design.Assume responsibility for the overall manufacturing process of new and existing products.Devise new approaches to complex problems through revisions of standard technical principles.Help prepare project plans, specifications, resource plans, and schedules for new product development.Work closely with other engineers, technicians, contract manufacturers, assemblers, or other support personnel to oversee manufacturing products for development prototypes, design verification, process development, and validation activities.Identify critical processes and develop master process validation plans including IQ, OQ, PQ, and external service validations requirements for development projects.Work closely with other engineers and assemblers to characterize and validate equipment and processes.Identify process inputs and outputs and develop strategies for how to monitor and control.Identify process performance requirements (yield, capacity, capability, efficiency) to be met before transfer to production and may be used as KPIs.Essential Skills8+ years of experience in medical device industry.Experience with catheter and electromechanical product work.Expertise in R&D process development, manufacturing engineering, process improvement, and design.Proficiency in process engineering, lean manufacturing, Six Sigma, and project management.Ability to manage KPIs, validation, ISO standards, new product development, and design control.Background in mechanical engineering.Additional Skills & QualificationsExperience with coronary IVL systems (balloon catheter and laser ablation).Work Environment

Very relaxed environment with a family-first mindset. Everyone feels part of the team and inclusive activities are structured, such as team lunches, outings, happy hours, and events. There is some flexibility to work from home depending on the workload and role, with an emphasis on work/life balance. The facility includes a fully operational golf simulator, full-scale gym, sauna, and locker room.

Pay and Benefits

The pay range for this position is $52.00 - $72.00/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 Brooklyn Park,MN.

Application Deadline

This position is anticipated to close on Feb 17, 2025.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are 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

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.