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Sr R/D Engineer

Plymouth, MN 55441

Posted: 08/30/2024 Employment Type: Contract Job Category: Engineering Job Number: 614299 Is job remote?: No Country: United States

Job Description


Additional position detail from the manager below:
 
  1. Can you please confirm your top 3 skills sets required?
    1. Analysis of technical specifications and requirements. 
    2. Testing/qualification of new components
    3. Design modification – translations into/ to specifications/requirements
  2. Can you please confirm the 3 main responsibilities/day to day activities required for this role?
    1. Review and analyze technical specifications and requirement documents
    2. Qualify new incoming parts
    3. Translate new requirements to suppliers
    4. Modify current design to align to newer product technology/requirements
  3. What products (if any) will this role support?  This will be supporting our RPE/Operations effort in the SE Stent VAVE effort (GPX,Everflex and Protégé stent lines)
  1. What is your target years of experience?  5-7 years - need someone that is independent and has enough experience

Responsibilities may include the following and other duties may be assigned.
  • Understands the requirements of cross-functional internal customers.
  • Understanding and wide application of technical principles, theories and concepts in the field.
  • Participates in preclinical evaluations.
  • Responsible for subset of product design. 
  • Develops product specs, test methods, equipment. Execute tolerance analysis.
  • Creates, reviews and approves protocols/reports.
  • Interprets test results.
  • Working knowledge of DRM and statistics.
  • Responsible for subsystems of designs or smaller designs in their entirety. 
  • Completes tasks associated with area of responsibility within assigned schedule. 
  • Solid understanding of regulatory indications and requirements, such as IDE, 510k, PMA’s, contributes to assigned sections of submission documents.
  • Working knowledge of internal quality system (e.g. SOPs, DOPs), external quality standards, and statistical methods.
Nice to Have (Preferred Qualifications)
  • Experience with medical device-based products, processes, and technologies
  • Medical Device/Pharmaceutical or other regulated industry experience
  • Design characterization and design selection experience
  • Experience with SolidWorks or AutoCAD
  • Proven experience executing product changes regulated by design control, applying product development process to derivative product line
  • Mechanical design experience -  modeling for devices and fixtures
  • Prototyping of devices and fixtures through 3d printing and/or machining; catheter device experience
  • Device design verification testing and test development

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Plymouth, MN

Ready to take the next step in your career? Explore job opportunities in the vibrant Plymouth, Minnesota area! Known for its picturesque parks, including the popular French Regional Park and the stunning golf course at Rush Creek, Plymouth offers a perfect blend of urban convenience and natural beauty. Home to iconic landmarks like Minnetonka Theatre and Eddington House, this bustling city boasts a rich arts scene and a thriving culinary landscape. Cheer on the local sports heroes at the nearby Target Center or take a leisurely stroll through the charming shops at The Shoppes at Arbor Lakes. With a plethora of opportunities for professional growth and a welcoming community atmosphere, Plymouth is the ideal place to grow your career. Browse our job listings today and discover your next adventure in this amazing city!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.