Position: Medical Device - Product Introduction Engineer
Leading Projects and Project teams to ensure Project Goals are met especially on time delivery, quality requirements and cost targets are achieved.
Planning, implementing and co-ordination of New Product Introductions to include: product design, product specifications, process validations identification of training needs, process & equipment lay-out, production procedures, material specifications, material & packaging procurement in accordance with VistaMed Procedures and Regulatory standards.
Sourcing and implementing tooling, equipment and technologies, as required to implement the manufacture of new and existing production. Co-ordinating the supply of extrusions, if required, with the Extrusion department including agreeing specifications of tubing, resins and quality requirements.
Ensuring effective and comprehensive customer communication throughout the duration of the project.
Planning and co-ordination to ensure that the necessary testing, evaluation & control of equipment measures are in place to monitor & support product quality in accordance with VistaMed Procedures and Regulatory standards.
Planning and co-ordinating New Product Design to include Design Inputs, Design Outputs, Design Verification and Design Validation including, where necessary, Clinical trials, Technical Files, Technical Reports and Design history Files in accordance with VistaMed procedures and Regulatory Standards.
Development of Manufacturing Process in conjunction with New Product Introduction Team including, as required, training of technicians, process operators and other staff.
Planning and implementing manufacturing cell lay-outs, work station design and material handling to ensure efficient manufacturing to meet product cost targets, efficiency targets and quality targets.
Leading Project management teams to ensure on-time task completion, effective team work, good motivation and effective communication.
Especially in the area of New Products but also existing products, participation in areas such as Customer Complaints, CAPA’s, etc., either as responsible for timely closure or providing technical support.
Completing any tasks within the project scope including validations, testing, product design and so forth.
Supporting the business acquisition process by way of completing quotations for piece part prices, equipment and other project costs. Providing technical support and customer communication as required.
Completing other tasks as assigned.
Engineering qualification in Polymer, Medical, Mechanical, Design or equivalent.
Minimum 3 years experience in new product introduction, manufacturing, quality or process engineering, preferably in catheter manufacturing.
Experience in Project Management regarding new product introduction, preferably in a Medical Device environment.
Fully PC literate.
Highly competent in catheter manufacturing processes, including extrusion, moulding, balloon forming, braiding, packaging and other assembly techniques.
Freudenberg Medical is a global partner for the design, development, and manufacture of innovative medical device technologies. We offer the following services to medical device, pharmaceutical and IVD clients worldwide - product design and development, silicone and thermoplastic moulding and extrusion, complex catheter systems, assembly, packaging, and engineering services.
For nearly 30 years, medical device and healthcare companies around the world have looked to Freudenberg Medical to make a difference as the custom manufacturer that medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Freudenberg Medical maintains design and manufacturing centres in California, Indiana, Massachusetts, Minnesota, Costa Rica, Europe and Asia.
VistaMed, a Freudenberg Medical Joint Venture Company are a leading provider of complex extrusions, finished catheters and devices to the minimally invasive medical device industry. We are a “one stop shop” solution for the Design, Manufacture, Assembly, Sterilisation and Distribution of Catheters. VistaMed’s Culture is positive and very team orientated. In our workplace environment, we are enthusiastic about helping others with our innovative medical devices. Our Company is very driven to be a leader in the Medical Device sector, and always eager to improve the quality of life in the patients in which we serve.
VistaMed is a local, innovative, high growth company with a collaborative, high performance work environment. Our highly talented teams of committed employees enable us to be the best, remain leaders in our field, and deliver first-class service to our clients. We understand that our team drive the company and therefore we are committed to ensuring personal development, safety, happiness and prosperity for all our employees.
Location: Carrick-on-Shannon, Co. Leitrim, Ireland
We are currently hiring a Medical Device - New Product Introduction Engineer:
Self-motivated, thrives in a fast-paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.
Strong interpersonal and communications skills.
Ability to manage multiple tasks and adapt in a challenging, fast paced environment.
It’s an exciting time to work in VistaMed. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus benefits. Learn more at (Please contact us using the "Apply for this Job Posting" box below) or .com
Freudenberg Medical and VistaMed are an equal opportunity/affirmative action employer