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.
- 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