Nonin Medical, Inc.

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Principal Mechanical Engineer

Principal Mechanical Engineer

ID 
2018-1162
# of Openings 
1
Job Locations 
US-MN-Plymouth
Category 
Product Development
Type 
Regular Full-Time

More information about this job

Overview

As part of the Continuation and OEM Engineering team, the Principal Mechanical Engineer is responsible for designing and implementing product enhancements and developing subsystems or engineering components of major projects.  Assignments are broad in nature, usually requiring appreciable initiative, originality, and ingenuity. 

   

Essential Job Functions:

  • Provide broad leadership, project execution, set technical direction, and course in area of technical expertise
  • Serve as technical leader for major development projects including development of devices in new technology
  • Responsible for design and development of mechanical/electromechanical systems
  • Responsible for activities which may include leading, participating, or supporting:
  • Concept, planning, design and execution stages • Risk assessment
  • Prototyping/testing • Pilot Production
  • Design reviews • Manual creation
  • Verification & Validation • Pre-production
  • Participate in the all phases across multiple projects of design; investigate interchangeability, replacement, cost factors, and ease of manufacture
  • Work with all project team members throughout the product development process in order to ensure that products are produced in a safe, efficacious and quality manner while keeping within established time frames
  • Prepare technical reports including Design of Experiments (DOE), External and Internal Design Specifications, Process Qualification, Validation Protocols/Reports, FMEA, and Statistical analysis
  • Research and recommend design options and perform experiments for potential design feasibility or application.
  • Assess and recommend design and development activities to including: time for completion, appropriate staffing, and/or use of outside resources to reach goals
  • Review product documentation for accuracy including documentation intended for customer use
  • Evaluate product non-conformances and recommend design modifications
  • Evaluate, test, and review designs to verify performance to requirements and specifications
  • Exercise wide latitude in determining objectives and approaches to critical assignments
  • Responsible for recording and sharing technical knowledge gained with colleagues
  • Train, mentor, and lead other engineers and technicians to ensure high standard of work
  • Promote an environment of continuous improvement across product lines and development groups
  • Work with other departments within the company to optimize production, diagnostics, and repair activities
  • Interact with external and internal design, quality, and manufacturing resources to design for manufacturability and test, reliability, and cost-effectiveness
  • 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 throughout the product’s life-cycle
  • Maintain accurate records throughout the development and support process in order to comply with company and government standards and/or regulations
  • Enable a design strategy that leverages modular design platforms to promote commonality, portability, and reusability of core elements, documentation, tools, and techniques

 

Minimum Qualifications:

Required Education & Experience:

  • Bachelor’s or Master’s degree in Mechanical Engineering or Biomedical Engineering with a focus on mechanical design, from an ABET-accredited university or college
  • 10+ years of experience in medical device mechanical design and manufacturing

Required Knowledge, Skills and Abilities:

  • Experience working in, and leading company-wide, cross-disciplinary teams
  • Experience with Pro-E/CREO 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
  • Experience training, mentoring, and leading other engineers and technicians
  • Experience communicating with external stakeholders, including engineers and preferably clinical end-users
  • Ability to drive accountability across project teams and functional team members
  • Highly polished personal communication skills. both written and verbal
  • Strong Computer skills (MS Word, Excel, PowerPoint, Outlook, Internet)
  • Familiarity with essential requirements of the Medical Devices Directive (MDD)
  • Self-Starter; Highly-Organized; Detail-Oriented; Highly-Motivated; Team Player; Analytical; Strong
    Interpersonal & Verbal/Written Communication
  • Customer-Focused; Results-Driven; Initiative; “Can-Do” Attitude

Preferred Qualifications:

  • Knowledge of pulse oximetry principles of operation
  • 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 designing for high volume manufacturing and/or automated assembly
  • Experience with mechanical design of human interface sensors
  • Extensive root-cause analysis experience
  • Knowledge of optics used in human interface sensors
  • Experience resolving heat transfer issues using theoretical analysis and modeling
  • SolidWorks experience
  • Proven technical expertise in technical area directly applicable to development of Nonin’s products
  • Demonstrated experience in successful project management

Physical Requirements:

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

 

Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.