Principal Engineer/Product Manager

? Lead Innovation in Med Devices! ?

Are you a Principal Engineer/Program Manager with 10+ years of engineering and 7+ years of project management experience in medical devices? We're seeking a hands-on leader to drive complex product development programs in Brooklyn Park, MN!

If you're passionate about bringing cutting-edge medical technologies to life, this is your opportunity to lead and make a significant impact.

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Key Responsibilities:

• Project & Program Leadership:
  
  
  
  
  • Own full-cycle development project plans and deliverables.
  • Track project progress and milestones, developing recovery plans for any deviations.
  • Serve as the primary liaison to key stakeholders, providing timely updates on project milestones, risks, and overall progress.
  • Lead core team meetings, setting clear goals and thoroughly documenting outcomes.
  • Apply appropriate project management techniques tailored to specific project needs and risks.
  • Resolve cross-functional barriers and effectively delegate tasks across the project team.
  • Collaborate closely with functional managers to address and resolve any resource constraints.
  • Manage the company's portfolio of programs as they relate to product development.
  • Work with various departments to ensure their needs are accurately incorporated into development plans.
  
  
• Technical Leadership & Execution:
  
  
  
  
  • Serve as a hands-on technical resource throughout the entire project lifecycle.
  • Perform investigational and early verification testing.
  • Evaluate and resolve project issues impacting manufacturability and reliability.
  • Engage with external vendors for equipment, components, or specialized services.
  • Contribute to the development of proprietary positions for the company.
  • Take a leadership role in the application and advancement of developed technologies.
  
  
• Team Development & Culture:
  
  
  
  
  • Build and coordinate high-performing, collaborative development teams.
  • Foster accountability and clarity within the team through strong communication and meticulous planning.
  • Promote a team-first mindset aligned with organizational values.
  • Mentor team members through example, emphasizing diligence, analytical thinking, and effective goal-setting.
  
  

Qualifications:

Requirements (Must-Haves):

• Bachelor of Science Degree in Engineering or a similar discipline.
• Minimum of ten (10) years of previous engineering experience.
• Minimum of seven (7) years of project management experience in a regulated medical device environment.
• Demonstrated experience leading medical device product development as a technical lead or principal engineer.
• Proven ability to manage a cross-functional team through the product development life-cycle.
• Working knowledge of Quality System Regulation (QSR) 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable medical device standards.

Preferences (Nice-to-Haves):

• Education or experience in research & development, design, or process development.
• Knowledge in the utilization of rapid prototyping, machine shop tools, and molding/extrusion methods.

• Program & Project Management: Full-cycle project ownership, milestone tracking, risk management, budget management, schedule adherence, resource coordination, recovery plan development.
• Technical Leadership: Medical device product development, hands-on technical support, investigational/verification testing, manufacturability/reliability assessment, vendor engagement, rapid prototyping, machine shop tools, molding/extrusion.
• Regulatory Compliance: QSR 21 CFR Part 820, ISO 13485, ISO 14971.
• Communication & Collaboration: Stakeholder liaison, cross-functional team leadership, core team meeting facilitation, conflict resolution, written and verbal communication across all levels.
• Problem-Solving: Creative problem-solving, sound judgment, analytical thinking, root cause analysis.
• Personal Attributes: Self-starter, strong multitasking capabilities, detail-oriented, adaptable, solution-focused, prioritization skills, accountability, diligence.

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.