Principal Systems Engineer in Minneapolis, MN at Apex Life Sciences

Date Posted: 6/13/2018

Job Snapshot

Job Description


Seeking a skilled and experienced engineer for a Principal role at a large medical device company in Minneapolis, MN. Must have AT LEAST 4 years of medical device experience to be considered.

All qualified candidates should send their up-to-date resume to jhambrose@apexlifesciences.com.

A Day in the Life

To provide engineering leadership in the design and development of innovative products for Renal Care Solutions through technical planning, system level evaluation, verification and validation. To provide engineering expertise on cross-functional development project teams and collaborate with other internal and external engineering groups.

Responsibilities Include:

  • Fluid system development defining the fluid circuits to support hemodialysis and peritoneal dialysis system
  • Provide engineering expertise in cross functional teams conceiving, evaluating and developing new white space opportunities
  • Develop solid understanding of targeted therapies and clinical applications
  • Ensure that device concepts and development plans meets targeted clinical application through systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints.
  • Lead, coordinate, execute, and document system analysis and design activities, including but not limited to security, safety, reliability, risk, usability and interface management
  • Establish and advocate for best practices and continuous improvement to mature the Systems Engineering knowledge and processes (CoE)
  • Generate and approve requirements and specifications for all aspects of product concept; ensure that all systems are developed in harmony and support each other.
  • Establish system verification and validation plan(s)
  • Plan and execute system level validation through pre-clinical evaluation.
  • Apply established SOP's, and/or develop new processes as needed, to ensure that newly developed devices meet established requirements and, where necessary, are approvable under applicable regulatory requirements
  • Assess system performance during the development process and provide feedback to these teams
  • Identify, and lead collaborations with internal and external engineering groups
  • Collaborate with quality and regulatory colleagues to ensure compliance
  • Participate in the identification and resolution of complex system issues through interfacing with engineers representing other components
  • Design, simulate and construct prototype devices for animal and human studies
  •  Collect, analyze, and model design inputs (voice of the customer, voice of the business, etc.) and transform them into high quality stakeholder and system requirements
  • Provide engineering review on current research projects, device concepts and data.
  •  Propose and champion new device concepts.

Must Have: Minimum Qualifications

  • 8+ years of experience with  a Bachelor’s Degree in a technical/engineering discipline; or
  • 6+ years of experience with a Master’s Degree in a technical/engineering discipline;

OR

  • 4+ years of experience with a PhD in a technical/engineering discipline
  • Development of fluid circuits using pumps, valves, and sensor
  • Solid understanding of fluid circuit control systems

Nice to Have

  • Significant breadth of knowledge in Quality, project planning, technical expertise, and all areas of product development.
  • Knowledge of dialysis device operation
  • Knowledge of FDA regulations and TÜV requirements
  • Knowledge of engineering resources/groups and track record of collaboration.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

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