Manufacturing/Process Development Engineer I-II

Posted 23 Days Ago
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Maple Grove, MN, USA
In-Office
Junior
Healthtech
The Role
The role involves coordinating product enhancements, generating documentation, ensuring compliance, supporting testing methods, and transferring projects to manufacturing.
Summary Generated by Built In

Join the growing team NP and help bring innovative medical device technologies to life. This role is perfect for someone who enjoys learning new processes, solving technical challenges, and working hands-on with advanced manufacturing technologies. If you are curious, collaborative, and excited to continuously expand your knowledge, you’ll fit right in with our team. Come be part of an environment where innovation, teamwork, and continuous learning drive everything we do.

Key responsibilities include:

  • Coordinates product enhancements with customers and internal project teams
  • • Help generate all required documentation in support of the development and manufacturing products and processes, including timelines, responsibilities, engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures.
  • • Work with quality and supply chain to ensure compliance with QSR and internal protocols.
  • • Review design and determine required Bill of Materials (BOM)
  • • Work with supply chain to obtain BOM pricing (from internal and external vendors)
  • • Support customer calls and presentations to compile product sustaining activities
  • • Provides support in the resolution of product complaints and/or safety issues.
  • • Help to conduct component and device testing methods and protocols.
  • • Identify risks to manufacturing sustainability- provide input to pFMEA and other risk assessment documentation
  • • Works with internal manufacturing as well as outsourced partners to develop metrics such as labor time, yields, statistical analysis, qualification and validation of process, tooling and equipment..
  • • Transfer as required engineering project from engineering into manufacturing.

Requirements
  • Bachelor's Degree in Engineering and one to three years of related experience and/or training, or equivalent combination of education and experience.
  • • Commitment to excellence and high standards
  • • Excellent written and oral communication skills
  • • Strong organizational, problem-solving, and analytical skills
  • • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
  • • Acute attention to detail
  • • Demonstrated ability to plan and organize projects
  • • Proven ability to handle multiple projects and meet deadlines
  • • Working knowledge of data collection, data analysis, evaluation, and scientific method.
  • • Working knowledge and understanding of the basic principles, theories, concepts,

PHYSICAL DEMANDS AND WORK ENVIORNMENT:


  • Frequently required to talk or hear.
  • · Frequently required to sit;
  • · Frequently required to use hand and finger dexterity, handle, or feel and reach with hands and arms.
  • · Occasionally required to stand; walk; climb or balance; stoop, kneel, or crouch.
  • · Frequently lift and/or move up to 25 pounds.
  • · Specific vision abilities required by this job include close vision.
  • · Occasionally exposed to risk of electrical shock and vibration
  • · Occasionally exposed to wet and/or humid conditions
  • · Occasionally exposed to moving mechanical parts
  • · Occasionally exposed to fumes or airborne particles
  • · The noise level in the work environment is usually moderate

Benefits
  • Health Care Plan (Medical, Dental & Vision)
  • Retirement Plan with Company Match
  • Paid Time Off, Personal Days, AND Birthday Holiday!
  • Lifetime Membership Subsidy and Wellness Resources
  • Life Insurance (Basic, Voluntary & AD&D)
  • Family Leave (Maternity, Paternity)
  • Short-Term & Long-Term Disability
  • Taco Thursdays!!!

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Top Skills

Engineering Protocols
Manufacturing Technologies
Statistical Analysis
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The Company
HQ: White Bear Lake, MN
172 Employees
Year Founded: 2000

What We Do

Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.​

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