Senior Engineer, Systems

JOB SUMMARY

The senior systems engineer interfaces with internal engineering staff and external robotics and software consultants and leads the system specification, design and technology development efforts for development of medical devices.  The Senior Systems Engineer performs Systems Engineering activities according to established procedures, including: drives system definition based on market and user needs; develops and maintains requirements throughout product life cycle across the entire product portfolio; leads, creates and defines product prototype workflows through coordination with cross-functional teams; develops and reviews validation methodologies to evaluate the performance of a system; coordinates transfer of system designs to production environments; etc.

DUTIES & RESPONSIBILITIES

• Participates in product development activities through the full product life cycle, including feasibility and prototyping, requirements generation, design and development, and technical review.
• Collaborates with external contractors on both product development and industrial design activities.
• Applies skills in system design & architecture, medical device quality management standards.
• Contributes to process and best practice improvement
• Designs clinical and product workflows.

SUPERVISORY RESPONSIBILITIES

• N/A

QUALIFICATIONS

Required Qualifications

• Must have 4+ years of experience in medical device development.
• Master’s degree in mechanical engineering, biomedical engineering, or related field or equivalent additional experience.
• Must have excellent communication and documentation skills.
• Strong experience in at least 2 of the following:
15. Authoring and managing design inputs (requirements, use cases, etc.)
16. Participation in medical device Risk Management activities per ISO 14971
17. Medical device design controls per ISO 13485
18. System level architecture
19. System verification and design validation experience
• Experience in robotics, algorithm design, modeling, and/or simulation a plus

Preferred Qualifications

• N/A

COMPETENCIES

• Drives results
• Optimizes work processes
• Decision Quality

PHYSICAL DEMANDS & WORK ENVIRONMENT

• Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
• Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
• Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
• Occasionally work around moving mechanical parts.
• Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
• Must be able to travel as business necessitates (up to % Travel %).

Disclaimer:

The above is intended to describe the general content of and requirements for the performance of this job.  It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements.  Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.