Senior Director, Regulatory Affairs
eGenesis, Inc.
Senior Clinical Systems Engineer
Medtronic
full-time
Posted on:
Location Type: Office
Location: North Haven • Connecticut, Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $104,800 - $157,200 per year
Job Level
Senior
About the role
- Support the Clinical Engineering team and Systems Center of Excellence for Robotic Assisted Surgical system
- Apply knowledge of the operating room environment and of medical technology as clinical expert
- Perform procedural research on current and future indications and instrumentation
- Maintain awareness of clinical applications of MDT Surgical Robotics products and transfer product knowledge to the team
- Pre-PDP/Opportunity activities: stakeholder interviews, procedural research, and case observations
- Translate user needs into customer/clinical requirements and define use conditions and clinical acceptability values
- Represent clinical setting, clinician, and patient throughout product development including user feedback sessions and formal user studies
- Develop system-specific setups to enable access to different anatomical workspaces and complex procedures
- Drive customer- and patient-centric product vision to ensure integration with clinical workflows
- Analyze user feedback and provide clinical input to systems engineering organization
- Support clinical evaluation of products at customer sites
- Engage Key Opinion Leaders and partner with stakeholders to expand Robotic Surgical Technologies program
- Support customer visits, conferences, and clinical advisory board activities
- Support engineering regarding clinical risks and mitigations
- Support FDA/regulatory documentation and applications and complaint handling related to clinical use, workspace access, and conversions
Requirements
- Bachelor’s Degree with 4 years of relevant experience, or a Master’s Degree with 2 years of relevant experience
- Engineering Degree in Biomedical, Robotic, or another applicable life sciences field (nice to have)
- 0-3 years of medical/clinical experience (OR tech, nurse, PA, medical device sales rep) (nice to have)
- Working knowledge of human anatomy
- Preferred experience with surgical terminology and minimally invasive products
- Experience with statistical tools (JMP, Minitab, MatLab)
- Solid problem solving and analytical skills
- Ability for interpreting, analyzing, and translating information
- Proven spatial / kinematic aptitude
- Strong presentation skills to a variety of audiences
- Comfortable communicating professionally with end users (surgeons, bedside assistants, nurses, field service technicians, sales reps)
- Demonstrated desire to learn and achieve
- Experience working with cross functional teams
- Ability to travel up to 25%, mostly domestic but occasional international travel may be required
- Physical ability to be independently mobile, interact with a computer, and communicate with peers and co-workers
Benefits
- Competitive Salary and flexible Benefits Package
- Eligible for Medtronic Incentive Plan (MIP) short-term incentive
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Short-term disability
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
- Paid time off
- Paid holidays
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical engineeringrobotic assisted surgical systemsprocedural researchclinical applicationssurgical robotics productsstatistical toolshuman anatomysurgical terminologyminimally invasive productsspatial aptitude
Soft skills
problem solvinganalytical skillspresentation skillscommunicationteam collaborationcustomer-centric approachuser feedback analysisstakeholder engagementdesire to learnadaptability
