Nonin Medical, Inc.

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Sr. Mechanical Engineer

Sr. Mechanical Engineer

ID 
2018-1190
# of Openings 
1
Job Locations 
US-MN-Plymouth
Category 
Product Development
Type 
Regular Full-Time

More information about this job

Overview

Primary Objective: The Senior Mechanical Engineer will develop solutions to field issues and design for upgrades for non-invasive medical device mechanical/electromechanical systems. Assignments are broad in nature, usually requiring initiative, originality, ingenuity and excellent problem-solving skills. Knowledge in the selection of various materials and adhesives for medical devices, extensive root-cause analysis experience, along with experience designing for high volume manufacturing are key areas that will set apart potential candidates. Experience designing for automated assembly and low cost is a plus.

Responsibilities

Essential Job Functions:

As part of the Continuation and OEM Engineering team, perform one or more of the following duties as assigned by an R&D Manager or Project Engineer to support the team’s goals:

  • Serve as team mechanical engineer for multiple simultaneous tasks and small projects.
  • Evaluate product non-conformances and recommend and implement design modifications.
  • Ability to work on complex issues requiring an in-depth analysis of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
  • Assist in project planning and provide mechanical design leadership in project execution.
  • Interact with global and internal design, quality and manufacturing resources to design for manufacturability and test, reliability and cost-effectiveness.
  • Review product documentation for accuracy including documentation intended for customer use.
  • Be a significant contributor in developing an environment of continuous improvement across product lines and development groups.
  • Analyze and provide feedback on peer designs in an open and collaborative design review forum.
  • Actively participate on, and at times lead cross-disciplinary teams to address design issues or maintenance of existing products.
  • Coordinate with project team to update and release product requirements, design specifications and design descriptions for applicable standards and procedures.
  • Responsible for recording and sharing technical knowledge gained with colleagues.
  • Evaluate, test, and review designs to determine if product will perform according to requirements and specifications.
  • Maintain accurate records throughout the development and support process in order to comply with company and government standards and/or regulations.
  • Mentor junior engineers to ensure high standard of work across all experience levels.

 

Qualifications

Required Education & Experience:

  • Bachelors degree in Mechanical Engineering or Biomedical Engineering with a focus on mechanical design, from an ABET-accredited university or college.
  • 7+ years of experience in medical device mechanical design and manufacturing.

Required Knowledge, Skills and Abilities:

    • Experience working in company-wide cross-functional teams
    • Experience leading cross-disciplinary teams.
    • Experience with Pro-E and AutoCAD.
    • Experience designing parts for plastic injection molding including insert molding and over-molding as well as integration of in-mold decoration (IMD).
    • Experience with rapid prototype design and build for proof of concept and usability testing.
    • Experience with DOE.
    • Ability to drive accountability across project teams and functional team members.

Preferred Qualifications:

  •  Knowledge of pulse oximetry principles of operation.
  • Experience communicating with external stakeholders, including clinical end-users and engineers.
  • Strong background in selecting medical-grade adhesives.
  • Experience with selection of materials for medical devices based upon biocompatibility requirements and materials interface needs.

Experience with Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment.

  • Experience with mechanical design of human interface sensors.
  • Knowledge of optics used in human interface sensors.
  • Experience resolving heat transfer issues using theoretical analysis and modeling.
  • SolidWorks experience.

 

Physical Requirements:

  • Ability to sit, stand and/or walk for 8 hrs/day.