Senior Sustaining Engineer

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.

The Senior Sustaining Engineer position is responsible for maintaining existing commercialized products post transfer by ensuring the products remain safe, compliant and optimized for manufacturing process performance.  In addition, the position provides quality engineering support for all phases of the product lifecycle at Surmodics.  This position is critical in driving continuous improvements to existing products to ensure they meet or exceed internal and external requirements. The ability to assess business and customer needs and risks in a fluid environment is essential for this role. 

Responsibilities 
Product Development (approx. 20-30%)
•    Provide technical expertise in design controls and risk management
•    Develop risk management plans and lead cross-functional risk management activities
•    Draft documents and provide technical review for document revision, review and approval
•    Maintain design history file and lead design review discussions
•    Support design transfer activities including new equipment qualification 

Purchasing & Supplier Controls (< 5%)
•    Support the investigation and resolution of issues related to supplied raw materials and services
•    Lead efforts to assess and qualify new or changed supplied raw materials

Continuation Engineering (approx. 70-80%)
•    Drive / support engineering activities for design and/or process changes to existing products by troubleshooting identified issues using good engineering practices, developing evidence-based project plans, and executing on deliverables
•    Implement opportunities to optimize/improve manufacturing processes and systems
•    Ensure strong cross-functional collaboration, timely multi-disciplinary input and compliance with regulatory standards and internal quality system requirements
•    Lead cross-functional activities for completion of risk management deliverables when changes are required; Perform risk management assessment for changes
•    Analyze and execute engineering change control efforts per established processes and manage the deliverables per QMS requirements
•    Analyze customer change notification requirements to support internal process changes
•    Lead discussions with customers to address quality issues and change notifications
•    Support product stability programs by reviewing protocols and reports 
•    Perform root cause investigations, propose corrective actions and oversee their implementation by using problem solving tools
•    Support complaint investigation efforts as needed, including returned product evaluation.
•    Develop and maintain key quality metrics

Validation (< 5%) 
•    Provide technical support to project teams
•    Draft and approve protocols and reports

Minimum Qualifications
•    Four-year technical degree with minimum 5 years’ experience in a Quality Engineering role or similar
•    ASQ Quality Engineering certification desired
•    Experience and training in process and equipment validation 
•    Extensive experience with QSR and ISO quality systems
•    Extensive experience with statistical techniques, measurement/trending and SPC tools
•    Strong attention to detail
•    Proficient computer skills- Microsoft Word, Access and Excel, statistical software (JMP, MINITAB)
•    Excellent analytical and problem-solving skills
•    Ability to read and follow detailed instructions including generating detailed instructions
•    Excellent written and verbal communication skills
•    Excellent interpersonal skills
•    Ability to prioritize activities relative to competing demands from multiple sources

Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.  

Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program.

Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.