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 internal and external requirements. Execute process development-related activities on projects. Review progress of projects and recommend appropriate revisions. Take a leadership role in the application and advancement of technologies.
ResponsibilitiesOversee process design, development, characterization, and validation for products in development.Work closely with R&D team, 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 strategy 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 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, PC, 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 strategy for how to monitor and control.Identify process performance requirements (yield, capacity, capability, efficiency) that should be met before transfer to production and may be used as KPI’s.Essential Skills8+ years of experience in medical device industryExperience with catheter/electromechanical product workProficiency in R&D process development, manufacturing engineering, process improvement, design, process engineering, lean manufacturing, Six Sigma, project management, KPI, validation, and ISOExperience in new product development, R&D, mechanical engineering, and design controlAdditional Skills & QualificationsAbility to devise new approaches to complex problemsStrong leadership skillsExcellent planning, organizational, and coordination skillsPay and Benefits
The pay range for this position is $57.00 - $65.00
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 will be accepting applications until Jan 1, 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 & InclusionAt 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 peopleThe 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.