Sr. Product Development Engineer

? Senior Engineer Opportunity in Med Device! ?

Are you a Senior Product Development Engineer with 5+ years of experience ready to lead cutting-edge projects? We're seeking a hands-on innovator in Brooklyn Park, MN, to design and develop groundbreaking medical devices!

If you're passionate about advancing healthcare technology and thrive in a collaborative environment, we want to hear from you!

Learn more & apply: [Link to Job Posting]

#MedicalDevices #ProductDevelopment #EngineeringJobs #NowHiring #SeniorEngineer #BrooklynParkJobs

Key Responsibilities:

• Design & Development:
  
  
  
  
  • Conduct advanced development work as a core part of major projects.
  • Under minimal supervision, perform analyses to develop precise design specifications and performance requirements.
  • Design, develop, and prototype new devices, components, and processes to meet customer needs, reduce costs, and enhance product quality.
  • Design and develop new test methods and equipment.
  
  
• Technical Guidance & Analysis:
  
  
  
  
  • Provide essential technical information concerning manufacturing or processing techniques, material properties, and process advantages/limitations in engineering planning.
  • Select and apply appropriate techniques to solve complex problems and provide sound design recommendations.
  • Perform, document, and report on thorough investigations and testing.
  • Author protocols and procedures for the testing, qualification, and validation of products and processes.
  
  
• Leadership & Project Management:
  
  
  
  
  • Lead cross-functional teams in the development of new products.
  • Manage product development projects, utilizing appropriate project management tools, to meet deliverables for time, quality, performance, and cost.
  • Coordinate high-level project plans, manage project risks, and drive overall project success.
  • Provide timely, appropriate, and accurate updates of project status and plans to management and project sponsors, including monthly reports, gate review records, and resource requirements.
  
  
• Collaboration & Compliance:
  
  
  
  
  • Work effectively with outside consultants, vendors, and the medical community.
  • Ensure that all quality system requirements are consistently met.
  • Support design reviews, board meetings, and physician visits.
  • Communicate effectively with teams and within the management structure to facilitate workflow and resolve project barriers and problems.
  • Responsible for notifying Quality Assurance/Quality Control of any observed or reported product quality issues for appropriate action.
  
  

Qualifications:

Requirements (Must-Haves):

• Bachelor's Degree in Engineering or a related field, or equivalent years of professional experience.
• Minimum of 5+ years of experience in engineering, specifically within product development.
• Ability to perform analyses to develop design specifications and performance requirements with minimal supervision.

Preferences (Nice-to-Haves):

• Active medical device experience, particularly with catheters.
• Experience with Quality System Regulation (QSR) 21 CFR Part 820, ISO 13485, and ISO 14971.
• Proven ability to lead cross-functional teams in product development.
• Experience managing product development projects utilizing project management tools.

• Product Development: Design, prototyping, component development, process optimization, new device development.
• Engineering Analysis: Design specifications, performance requirements, technical information analysis, problem-solving, design recommendations.
• Testing & Validation: Test method development, equipment design, investigation, documentation, protocol authoring, product qualification, process validation.
• Project Leadership: Cross-functional team leadership, project management (time, quality, performance, cost), risk management, communication.
• Collaboration: Working with external consultants, vendors, and medical professionals.
• Quality Systems: Understanding and ensuring compliance with quality system requirements.

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.