Senior Development Engineer

Steris Corporation•Mentor, OH

8d•Hybrid

About The Position

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary 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.

Requirements

Bachelor's Degree in Engineering
5+ years of relevant work experience
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

Nice To Haves

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

Responsibilities

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.