Work within a multidisciplinary product development team specifically focused on in-vitro diagnostic and medical device systems
Collaborate with cross-functional team members to define and continuously improve our TEG product platform
Define and translate user needs into product requirements and assist in translating requirements into design specifications
Develop and review test protocols, ensuring traceability to requirements and specifications
Identify and mitigate risks through design, development, and testing strategies
Provide technical support for regulatory submissions, including gap analysis and test proposals
Facilitate group problem-solving and decision-making activities
Communicate risks and mitigation strategies during project planning
Analyze data and evaluate the applicability of technical recommendations
Coordinate work across project teams and departments with proactive communication
Maintain sensitivity in communications with culturally diverse audiences
Apply advanced knowledge of specialized disciplines to support product needs and customer requirements
Requirements
Bachelor’s degree in electrical, mechanical, biomedical, computer engineering, or equivalent
At least 5 years of hands-on technical experience in complex multidisciplinary product development, including one large product through its full development lifecycle
A minimum of 2 years’ experience in medical device or in-vitro diagnostic (IVD) development under FDA Quality Systems Regulations, CE Marking, and ISO Quality System
Systems thinking approach considering the product lifecycle, environment, users and stakeholders
Practical knowledge of requirements and risk management strategies and approaches
Strong technical and leadership skills within the applicable discipline
Excellent interpersonal and administrative skills
A continuous improvement mindset
Systems engineering training or certification preferred
Some training or certification in Six Sigma methodologies preferred
Benefits
401(k) with up to a 6% employer match and no vesting period
Employee stock purchase plan
Flexible time off for salaried employees
Accrual of three to five weeks’ vacation annually (based on tenure)
Accrual of up to 64 hours (annually) of paid sick time