Senior Development Engineer

The Senior Development Engineer leads design and development efforts for gastrointestinal endoscopy devices or major subsystems, driving activities throughout the product life cycles from concept to product release to sustaining. This role owns design control deliverables, including requirements definition, risk management activities, and verification and validation strategies.

The position provides technical leadership within cross functional teams, supports design reviews, and ensures alignment across engineering, quality, regulatory, clinical, product management, project management, and manufacturing functions. The Senior Development Engineer is expected to proactively identify technical risks, influence design decisions, mentor other engineers, drive forward progress towards milestones, and achieve compliance to applicable standards and regulations.

• Lead design and development of medical devices or major subsystems activities throughout the product life cycles from concept to product release to sustaining.
• Own design control deliverables, including requirements definition, risk management, and V&V strategy.
• Develop and execute verification and validation plans aligned with regulatory and quality requirements.
• Identify technical risks (threats and opportunities) and proactively drive strategies to minimize threat impact or maximize opportunity gain
• Make sound technical trade offs balancing performance, quality, cost, and schedule. Integrate input from technical, manufacturing, and marketing disciplines. Create and drive a product development plan according to established company practice and all associated support documentation.
• Generate detailed, high quality technical documentation to communicate designs and decisions. Must be able to present updates to technical and non-technical audiences (project meetings, board meetings, etc.) This position may be required to solely represent the design function in key meetings.
• Provide technical leadership within cross functional teams. Work closely with the Design Engineer to support all Intellectual Property activities such as documenting design ideas in an IP Assessment, confirming freedom to operate, reviewing patent filings, and discussing patents with internal or external patent attorneys.
• Integrate input from clinical, manufacturing, quality, and marketing disciplines.
• Mentor Development Engineer I and II team members. As resources allow, supervise an engineering co-op in their daily and weekly work responsibilities.
• Identify and implement improvements to internal processes and development practices.

• Bachelor's Degree in Engineering and 5+ years of relevant work experience with the following:
  
  
  
  • Experience leading device or subsystem development from concept to release
  • Ownership of design control deliverables and DHF content
  • Experience developing and executing V&V strategies
  • Experience identifying and mitigating technical risk
  
  
  
  

• Preference for technical ownership of complex projects
• Experience integrating input from clinical, manufacturing, and quality disciplines
• Interest in mentoring less experienced engineers
• Comfort making design trade offs with limited data
• Desire to influence technical decisions within programs
• Advanced technical problem solving and analytical skills
• Ability to make sound decisions using good enough information
• Strong written and verbal communication with technical and non technical audiences
• Mentorship and technical leadership skills
• Ability to balance quality, cost, and schedule considerations

At STERIS, we invest in our employees and their families for the long term! STERIS wouldn't be where it is today without our incredible people. We share our success together with you by rewarding you for your hard work and achievements.

Here is just a brief overview of what we offer:

• Competitive Pay
• Extensive Paid Time Off and (9) added Holidays.
• Excellent healthcare, dental, and vision benefits
• 401(k) with a company match
• Long/Short term disability coverage
• Parental Leave
• Additional add-on benefits/discounts for programs such as Pet Insurance
• Continued training and educations programs
• Excellent opportunities for advancement in a stable long-term career
• #LI-KS1 #LI-Hybrid