Principal Product Engineer

Senior Medical Device Engineer Alert!

Are you a Principal Product Development Engineer ready to lead complex projects from concept to launch? We're seeking an innovator with 10+ years of experience and deep knowledge of QSR, ISO 13485, and ISO 14971 to join our team in Brooklyn Park, MN!

This is your chance to drive cutting-edge medical device innovation and contribute to proprietary technologies. If you're a hands-on leader, apply today!

Key Responsibilities:

• Leadership & Strategy:
  
  
  
  
  • Work closely with customers and internal stakeholders to define comprehensive product specifications and guide product realization efforts.
  • Perform complex engineering and technical work involved in planning, organizing, and coordinating detailed information for new product development.
  • Develop and manage strategies to steer products efficiently through the entire engineering cycle.
  • Budget operational activities, ensuring continuous funding based on strategic priorities.
  • Coordinate and contribute to intellectual property strategies for new technologies.
  
  
• Product Development & Innovation:
  
  
  
  
  • Execute detailed product design through strict adherence to established design control processes.
  • Design and develop prototypes and feasibility models for robust proof-of-concept testing.
  • Assume overall responsibility for device design and provide essential support for the manufacture of both new and existing products.
  • Devise novel approaches to solve complex technical problems by creatively revising standard engineering principles.
  • Prepare and contribute to project plans, specifications, and schedules for new product development initiatives.
  • Collaborate closely with other engineers, technicians, contract manufacturers, assemblers, and support personnel to assist in debugging and optimizing system performance.
  
  
• Analysis & Compliance:
  
  
  
  
  • Compile and analyze operational, test, and research data to establish precise technical specifications and performance standards for newly designed or modified products and processes.
  • Review project progress against design criteria and industry standards, recommending appropriate revisions as needed.
  • Ensure compliance with applicable regulatory, customer, and internal requirements throughout the development lifecycle.
  
  

#LI-AR2

Qualifications:

Requirements (Must-Haves):

• Bachelor's Degree in Engineering or a related technical field, or equivalent experience.
• Minimum of 10+ years of progressive experience in an engineering role.
• Must have hands-on experience and working knowledge of Quality System Regulation (QSR) 21 CFR Part 820, ISO 13485, and ISO 14971, along with other relevant medical device standards.

Preferences (Nice-to-Haves):

• Demonstrated experience with medical device prototyping, development, and manufacturing within a contract manufacturing environment.
• Prior experience with balloon catheters, delivery systems, reinforced/steerable catheters, nitinol components, or biomedical textiles.
• Proven ability to work collaboratively in cross-functional teams.
• Strong organizational skills with the ability to manage multiple projects and priorities effectively.

• Product Development Lifecycle: Concept to realization, design control, design validation, process validation.
• Medical Device Regulations: QSR 21 CFR Part 820, ISO 13485, ISO 14971.
• Engineering Principles: Data analysis, technical specification development, root cause analysis, statistical analysis, continuous improvement.
• Prototyping & Testing: Design of prototypes, feasibility models, test plan development, system debugging, optimization.
• Leadership: Project coordination, strategic planning, budgeting, intellectual property coordination, customer collaboration.
• Technical Documentation: Preparation of project plans, specifications, and schedules.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.