Senior Systems Engineer

Role Overview

• 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
• Paid and/or floating holidays
• Parental leave
• Short
• and long-term disability insurance
• Tuition reimbursement
• Health and welfare benefits