Product Engineer I - Sustaining

Position Summary

The Product Engineer I - Sustaining is responsible for all design aspects of our products after a product is released for production. Responsibilities include design and design control for product changes that result from supplier changes, quality improvements, new or changing regulations and standards, performance improvements, and cost reductions.  Projects must be completed accurately, within compliance, and quickly to avoid stock-outs.  The position should also actively seek areas for improvement in internal processes and create innovative solutions in both product design and process flow. The engineer is responsible for assisting in CAPAS, NCR’s, and complaint investigations.

What You'll Do as a Sustaining Engineer I

• Work within cross-functional team structure to ensure projects maintain momentum, meet timelines, and collective good decisions are made regarding design, materials, manufacturing, quality, costs, regulatory compliance, and intellectual property.
• Responsible for product design including CAD design, prototyping, and design control documentation including input/output specifications and risk management files.  Engineer is responsible for writing product verification and validation protocols and leading various teams in product risk assessments (hFMEA); maintain design history file documents in accordance with the Quality Management System
• Work independently or with other engineers as well as clinicians and marketing representatives to review design ideas and prototypes; proactively coordinate, direct, and perform design activities related to GI endoscopic devices and accessories that were previously released for manufacturing.
• Ability to determine engineering related design control requirements when assigned a project/problem with regards to a currently marketed device. 
• Interpret and evaluate data from engineering research and/or marketing investigations to determine the performance requirements that will be incorporated into the product. 
• Work with NPD teams to ensure smooth Design Transfer of New Products into production Work with multiple different groups of people to ensure minimal risk to the production floor (including stock-outs) when introducing a change. 
• Leads or assists with resolution and mitigation of CAPAS, NCR’s, and complaints.
• Develop technical knowledge in areas such as materials, plastics, molding, welding, component assembly, and packaging, to effectively design and support the technical needs of the organization.
• 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 design function in key meetings.
• Suggest areas for improvement in internal processes and create solutions. Help to create streamlined processes for varying tasks.

The Experience, Skills and Abilities Needed

Required:

• Bachelor’s degree required in Engineering or related technical field
• 1+ year of relevant work experience (internship and/or co-op experiences do qualify)
• Knowledge of design control
• Mechanical design knowledge
• CAD experience - SolidWorks preferred

Preferred:

• Understanding of medical device regulations and quality control
• Knowledge of IEC and ISO standards surrounding medical electrical equipment, quality systems, and risk management requirements
• Proven ability to innovate with a history of successful product releases (medical devices a plus).
• Use of a customer driven approach to problem solving and product design is desired

Other:

• Excellent engineering and organization skills and ability to work independently or within groups.
• Strong interpersonal skills
• Excellent verbal and written communication skills
• Ability to accurately obtain, record, and communicate test data to non-technical personnel.
• Must be able to travel domestically to observe clinical usage, attend conferences, and participate in animal or bench tests.

What STERIS Offers

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future.

Here is a brief overview of what we offer: 

• Market Competitive Pay
• Extensive Paid Time Off and (9) added Holidays
• Excellent Healthcare, Dental and Vision Benefits
• Long/Short Term Disability Coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add-on benefits/discounts for programs such as Pet Insurance
• Tuition Reimbursement and continued education programs
• Excellent opportunities for advancement in a stable long-term career