Tech Lead Systems Engineer - Location – New Jersey - US State

Job Type:
IT leadership
$130,000 - $140:000
Ref #:

In this role you will be responsible for:

Strategy & Planning

  • Definition and management of requirements to include characterization of those systems/devices that leads to verification and validation.
  • Participates in Design and Technical Reviews to ensure customers’ needs are satisfied and designs are consistent with the system-level requirements.

Operational Management

  • Works closely with program managers and multi-functional team members to identify and mitigate technical issues to reduce programmatic risks.
  • Frequently interacts with senior functional leaders, including Marketing, Program Management, Operations, Quality, Business Platforms, Medical, and Regulatory to ensure that the system/device under development meets overall business needs.
  • Conduct bench studies, tolerance stack up analysis, FMEAs, design verification, validation, vendor interactions, materials specifications and component specifications.
  • Ensures compliance with company quality policies, procedures, standard methodologies, all applicable local, state, federal and company laws and regulations.

To be successful in this role, we require:

  • Expertise in common risk management techniques (FMEA).
  • Experience in modeling, simulations and sensitivity analyses.
  • Proficiency with basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies.
  • Experience with design standard methodologies, including advanced tolerance design, and design for reliability.
  • Validated analytical and creative problem-solving abilities.
  • Ability to work in a collaborative setting

Must Have Demonstrated Experiences in:

  • Validated experience in design, development, and implementation of medical device systems, applications, and related products.
  • Owning, authoring, and developing needs statements while collaborating with various partners.
  • Owning, authoring, and developing system and sub-system requirements (or works with sub-system associates) by decomposing needs statements
  • Creating and maintaining needs, requirements, and traceability within a requirements management tool
  • Owning, authoring, and maintaining system architecture documentation.
  • Developing options and trade-offs and drives discussions to outcomes.

Education and experience required:

  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering or similar
  • Minimum of 8 years of post-educational professional experience

Preferred Qualifications and Knowledge:

  • Graduate degree (MS or Phd) in Systems Engineering, Mechanical Engineering, Biomedical Engineering or similar
  • 10+ years of post-educational experience in Medical Device Design
  • INCOSE Certified Systems Engineer
  • Knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and ISO 80369 and collateral standards

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