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.
Overview
The Manufacturing Engineer will be responsible for performing a variety of technical and support roles to the Production / Manufacturing department. Surmodics offers a competitive compensation and benefits package, including an attractive 4 day working week shift pattern.
Responsibilities .
- Provide technical support on all product and processing related issues.
- Manage production processes ensuring that target yield, capacity, throughput time and productivity are achieved.
- Apply “Lean” principles to production considering flow optimisation, throughput time, product movement, layout, and space.
- Specification, Procurement, Installation, and Validation of Manufacturing Equipment. This will include on site Factory Acceptance Testing of equipment.
- Set up Preventive Maintenance and Calibration routines.
- Provide ongoing day to day support to Balloon Forming production; continually seeking to drive improvement in operation performance while also maintaining highest levels of regulatory conformance. Effectively trouble shoot production related issues, implementing “robust permanent fix” solutions.
- Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Work Instructions, Manufacturing procedures and Logs.
- Manage Tooling and Equipment spare parts inventory to support manufacturing capacity.
- Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations
- Partner with R&D, Quality and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
Qualifications
- Engineering Degree or equivalent.
- A minimum of 3 years’ engineering experience working in a similar role. Balloon manufacturing and polymer processing knowledge are highly desirable.
- Strong technical understanding of set up and maintenance of balloon manufacturing processes. Experience in validation, equipment design and Lean Manufacturing highly desirable.
Competencies and Attributes
- Proven technical expertise and competence across all aspects of manufacturing engineering function including lean.
- Demonstrated expertise and detailed knowledge of the medical device industry.
- Equipment Procurement and Validation experience.
- Has conducted IQ/OQ/PQs and/or validations previously in a regulated environment.
- Effective knowledge of the regulatory environment in which the business operates.
- Proven written and oral communication skills and an ability to prepare competent business cases.
- An analytical approach to problem solving.
- Good oral communication skills and capacity to represent the company to customer and representatives of regulatory bodies.
- Is creative, continually learning and exploring new ideas.
- High level of flexibility required with regard to role and prioritisation of activities.
- A self-starter applies his/her own initiative in most situations.
- A good team player who works well in a team environment.
- Capacity to maintain the highest levels of confidentiality internally and externally.
- Ability to stay connected to multiple projects simultaneously.
Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sexual orientation, gender identity, national origin, disability, civil status or members of traveller communities.