Senior Development Engineer

Req ID: 44889

Job Category: Engineering

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. Ensure that collective good decisions are made regarding design, materials, manufacturing, quality, costs, regulatory compliance, intellectual property, and strategic fit within the product portfolio.

• 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 the design engineer to implement best practices that help reduce technical risks and meet timeline goals.

• Work with the Design Engineer to create an engineering plan for the project that will meet the timeline of the overall project schedule.

• Work with a cross-functional team to identify user needs and project requirements and then translate those into design specifications. Integrate input from various sources such as clinical, quality, engineering, manufacturing, and marketing disciplines.

• Interpret and evaluate data from engineering research and/or marketing investigations to determine the performance requirements that will be incorporated into the product. Observe device/prototype performance in lab or initial market release for future verification and validation requirements.

• Work with the project manager, marketing, clinicians, and design engineers to obtain feedback on design ideas and prototypes.

• 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, etc..

• 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.

• Must be able to present project updates to technical and non-technical audiences (project meetings, board meetings, etc.) This position may be required to solely represent the engineering function in key meetings.

• Identify areas for improvement in internal processes and create solutions. Help to create streamlined processes for varying tasks.

• Develop technical knowledge in areas such as materials, plastics, molding, welding, component assembly, and packaging, in order to effectively support the technical needs of the organization.

• 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.

• Ability to review and understand project timelines, identify key tasks and milestones, and be able to create an engineering plan that reduces technical risks in order to meet the overall schedule.

• Understanding of processes related to reviewing existing and protecting novel Intellectual Property.

• Fluent in Microsoft Office Applications (e.g. Word, Excel, PowerPoint, Outlook, etc..)

• Experience in 3-D solid modeling/drawing environment (SOLIDWORKS preferred)

• Must communicate effectively verbally and in writing.

• Strong interpersonal skills

• Ability to focus on priority tasks, learn new things quickly, and deliver creative and simple solutions to complex and challenging opportunities. Ability to prioritize projects based on corporate strategy.

• Must have a commitment to teamwork and quality, and be able to manage multiple projects concurrently, while satisfying changing customer (internal and external) needs and priorities.

• Must be able to present project updates to technical and non-technical audiences (project meetings, board meetings, etc.)

Preferred Experience

• Experience in working directly with physicians, clinicians, and/or medical technicians in gathering voice of customer feedback on product requirements and user needs.

• Work within a cross-functional team to identify user needs and design requirements in order to develop a product.

• Proficiency in various component manufacturing and device assembly methods in order to support design for manufacturability.

• Experience with Lean Design/Development methodologies

• Experience with Human Factors/Usability Engineering

• #LI-KS1 #LI-Hybrid

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Req ID: 44889

Job Category: Engineering

Mentor, OH, US, 44060

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