Senior Development Engineer

Job Title : Senior Development Engineer

Please read the following job description thoroughly to ensure you are the right fit for this role before applying.

Req ID : 44889

Job Category : Engineering

Location : Mentor, OH, US, 44060

Description :

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 STERIS Procedural GI business unit is seeking a motivated, intelligent, curious, and driven engineer for an open Senior Development Engineer position to help drive collaborative innovation and product launches for the Therapeutic Value Stream.

Development Engineers at STERIS Endoscopy are responsible for the development and release of innovative products to better diagnose, prevent, and treat disease of the gastrointestinal tract.

You will work closely with Design Engineers, Project Management, Cross-Functional Teams, Clinicians, Physicians, vendors, and external resources to turn user needs into viable solutions.

Development Engineers are responsible for facilitating design and development of products, design controls, risk management, product qualification, product clearance, and product release.

Duties :

• Develop GI endoscopic medical devices from concept development to full market release by working within a cross-functional team structure to ensure that the assigned project meets user needs, engineering deadlines and budgets.
• Work closely with the Project Manager by discussing project planning, key project decisions, user needs and product requirements, and providing updates on key engineering tasks, technical risks and engineering milestones.
• Provide engineering updates to the CFT in a clear and concise manner.
• Support the Design Engineer by helping to identify and communicate product requirements, potential design options, and timing goals for key engineering activities.
• Work with a cross-functional team to identify user needs and project requirements and then translate those into design specifications.
• Interpret and evaluate data from engineering research and / or marketing investigations to determine the performance requirements that will be incorporated into the product.
• Responsible for product development documentation such as 510(k) testing protocol and report, sterilization testing or adoption, biocompatibility testing protocols and reports, and engineering reports documenting key decisions and rationale.
• Work closely with the Design Engineer to support all Intellectual Property activities.
• Must be able to present project updates to technical and non-technical audiences.
• Identify areas for improvement in internal processes and create solutions.
• Develop technical knowledge in areas such as materials, plastics, molding, welding, component assembly, and packaging.
• As resources allow, supervise or mentor an engineering co-op in their daily and weekly work responsibilities.

Required Experience :

• Bachelor's in Biomedical Engineering, Bioengineering, or Mechanical Engineering.
• 3+ years of industry engineering experience (or 2+ years with relevant co-op experiences).
• Proven ability to innovate with a history of successful medical device new product releases.
• Understanding of medical device regulatory, document, and quality control issues.
• Fluent in Microsoft Office Applications.
• Experience in 3-D solid modeling / drawing environment (SOLIDWORKS preferred).
• Strong interpersonal skills and ability to focus on priority tasks.

Preferred Experience :

• Experience in working directly with physicians, clinicians, and / or medical technicians.
• Experience with Lean Design / Development methodologies.
• Experience with Human Factors / Usability Engineering.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only.

STERIS is an Equal Opportunity Employer.

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