Full-Time

Senior Sustaining Engineer

Surmodics

Surmodics

201-500 employees

Surface modification technologies for intravascular devices and diagnostic


Senior

Eden Prairie, MN, USA

Required Skills
Management
Requirements
  • BS or advanced degree in engineering or related discipline
  • 5+ years medical device experience in engineering function
  • Expert knowledge of Design Control and Risk Management
  • Knowledge of problem-solving methodologies and approaches
  • Experience with Quality Systems as outlined in CFR820/ ISO13485
  • Experience leading CAPA investigations and developing effective corrective actions that utilize a risk-based approach
  • Excellent facilitation and presentation skills
  • Strong ability to communicate (written and verbally) within and across disciplines and organizational structures
  • Ability to manage competing priorities in a fast-paced environment
  • Demonstrated use of Quality tools and methodologies
  • Practical knowledge of applied statistics, including statistical analysis tools (Minitab, JMP, etc.)
  • High attention to detail, organization, and accuracy
  • Ability to plan and implement technical tasks that may not be well-defined, have multiple variables and require advanced implementation techniques
Responsibilities
  • Drive engineering activities for design and/or process changes to existing products by developing evidence-based project plans and executing on deliverables.
  • Ensure strong cross-functional collaboration, timely multi-disciplinary input and compliance with regulatory standards and internal quality system requirements.
  • Standardize and drive the forum to gather, prioritize, and estimate effort for sustaining activities across product lines with cross-functional teams.
  • Leads design verification, design validation, usability and test method validations activities for design changes to meet or exceed internal and external requirements.
  • Develop, drive execution, and implement design inputs and design outputs for changes to existing products. Develop new test methods and/or revise existing test methods to support the changes. Execute or lead execution on test method validations.
  • Cross-functional leader for completion of Risk Management deliverables when changes are required. Perform risk management assessment for changes.
  • Collaborate and oversee both product and process changes at Contract Manufacturing Organizations (CMO) as part of a Surmodics core support team
  • Manage Quality System processes necessary to properly document and assess sustaining activities.
  • Perform root cause investigations, propose corrective actions and oversee their implementation by using problem solving tools.
  • Support complaint investigation effort as needed, including returned product evaluation, testing, and health risk assessment.
  • Support regulatory approvals and responses to regulatory agencies' questions.
  • Accountable for the implementation of opportunities to optimize/improve manufacturing processes and systems.
  • Execute engineering change control efforts per established processes and manage the deliverables per QMS requirements.
  • Coordinate design/process change implementation into production.
  • Other activities as assigned

Surmodics, Inc. stands as a global leader in surface modification technologies for intravascular medical devices, demonstrating its industry leadership by also being a top provider of chemical components for in vitro diagnostic tests and microarrays. The company's competitive advantage lies in its commitment to addressing unmet clinical needs by designing and producing highly differentiated medical devices, engineered to the most demanding requirements. The culture at Surmodics fosters technical innovation, as evidenced by its continuous pursuit of advanced medical solutions.

Company Stage

IPO

Total Funding

$125M

Headquarters

Eden Prairie, Minnesota

Founded

1979

Growth & Insights
Headcount

6 month growth

0%

1 year growth

-1%

2 year growth

1%