Biomedical Engineer – Software Systems
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Job Description
Biomedical Engineer developing software systems supporting full life cycle of software applications at Arthrex, a global medical device leader.
Responsibilities:
- Supports Software Development Life Cycle (SDLC) of software projects/programs
- Supports the establishment of design inputs and system level software requirements
- Participates in the development of project plan, design and development plan, and specifications including transferring the product requirements to software use cases and acceptance criteria
- Collaborates on software test plans, assessing risk profiles, supporting risk management file creation
- Creates and maintains software product Design History Files (DHF)
- Ensures completion of Design Control Documentation
- Participates in the review of software product complaints and performs root cause failure analysis
- Supports Quality System Audits conducted by external agencies, such as FDA, Notified Body and/or Regulatory Agency audits
Requirements:
- Excellent communication and analytical skills required
- Bachelor's degree in Biomedical Engineering strongly preferred
- Strong technical project management skills required
- Experience supporting complex, cross functional teams independently required
- Knowledgeable of application of systems engineering required
- Knowledgeable of basic FDA and ISO guidelines for the development of medical grade software required
- Project management and communication skills training preferred
- Software agile (SDLC) process knowledge preferred
- Historical perspective on orthopedic surgery principles, theories, and products preferred
- 2 years of relevant work experience required
Benefits:
- Medical, Dental and Vision Insurance
- Company-Provided Life Insurance
- Voluntary Life Insurance
- Flexible Spending Account (FSA)
- Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
- Matching 401(k) Retirement Plan
- Annual Bonus
- Wellness Incentive Program
- Gym Reimbursement Program
- Tuition Reimbursement Program
- Trip of a Lifetime
- Paid Parental Leave
- Paid Time Off
- Volunteer PTO
- Employee Assistance Provider (EAP)
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