Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.
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 Process Development Engineer provides project level leadership and execution for new product development projects, taking accountability for all process development and verification / validation activities from design freeze through production transfer. Influences design to ensure manufacturability and develops appropriate process capability.
- Leads all process development and production transfer activities, providing technical leadership from Design Verification through initial finished goods units
- Leads process development activities required to achieve COGs targets for specific products
- Delivers PVAL results (IQ. OQ. PQ, PPQ).
- Develops and completes PFMEA and Master Validation Plan utilizing contemporary statistical techniques
- Collaborates with Production planning to transfer new processes to commercial manufacturing
- Develops and teaches best practices in process development and provides vison for connectivity with other product development disciplines
- Supervise direct reports including reinforcing the open-door policy and ensuring duties, responsibilities, authority and expectations for direct reports are defined and understood
- Interview, select, train and evaluate performance of new hires to staff the department with motivated and skilled professionals
- Provides input to organization strategic planning
- Identifies methods to measure system performance and drive systemic improvements
Note: 90+% of this job involves direct New Product Development activities
- Bachelor’s Degree preferred
- With a degree, four years of relevant experience is required
- Without a degree, seven years of relevant experience is required
- Demonstrated skill and aptitude in the areas of Process Validation, Risk Analysis, and Design Verification and Validation; both in concept and in current industry best practice
- Must possess working knowledge of quality system regulations, strong project management, written and oral communication skills
- Ability to identify, plan, lead and execute the process development segment of a product development project.
- Understanding of budget and planning process and implementation
- Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, adhesive and thermal bonding and various other processes for catheter fabrication and design required
- Strong technical knowledge of materials, processes, and equipment common to the development and manufacturing of disposable medical devices (e.g. PTCA catheters), process conception and development, test methods and metrology, documentation, and a working knowledge of medical device regulations
- Ability to effectively provide leadership and vision to technical staff is same dicipline
- Ability to provide strategic resource and budgetary planning; to set vision and coordinate actions/output of a group on multiple simultaneous programs in support of an overall organizational strategy.
- Travel up to 10%
Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.
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.