Senior NPI Engineer (Spiddal Galway)

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

About Aran Biomedical (Integer)

Aran Biomedical design, develop and manufacture implantable medical devices, as an outsource partner to many of the leading, global medical device companies. Our innovative technology focus and biomaterials expertise foster a dynamic culture, which delivers next-generation implantable solutions. Aran Biomedical’s facility is situated along the Wild Atlantic Way in Spiddal, overlooking the Galway Bay and is just 20 minutes from Galway City by car. As we continue to grow and expand our facilities, we are looking for like-minded people to come and join our team.

About the Role

The position requires an experienced and proven candidate with a background in managing the commercial transfer of innovative product-designs within GMP/FDA/ISO regulated medical devices industry. Candidates must have a minimum of 5 years of experience in the transfer of products and packaging-systems from design-freeze through qualification to commercial manufacturing. The successful candidate will be part of an NPI (New Product Introduction) team of engineers and technicians to work cross functionally with Quality, Operations, Design Services, Materials , Health and Safety and Facilities groups. This position will require an ability to work autonomously whilst providing communication updates to all levels of the organisation including the site Leadership team and external customers.

Duties and Responsibilities

• Coordinate and manage teams in meeting internal and external (customer) quality, timeline and budget commitments in transferring product and packaging designs into fully qualified commercial manufacturing processes.
• Foster strong collaborative partnerships with technical leads and cross-functional team members to develop accurate transfer roadmaps and timelines.
• Provide regular project status update-presentations to customers and the business.
• Drive strong adherence to all stage gate reviews for quality and business purposes.
• Lead all process development discussions with internal and external stakeholders and participate in the definition and final agreement of achievable and cost-effective commercial transfer activities.
• Plan, implement and co-ordinate new product introductions through:
  • Scaling, development, and validation of product and packaging.
  • Equipment procurement and facility layout for new production lines or line extensions.
  • Initial capacity planning and identifying production operator requirements to meet customer forecasts.
  • Development of Production and Quality operating procedures.
  • Material sourcing and procurement including supplier qualification and raw material specifications.
• Support quality system requirements through management and compliance to the Product Development Process (PDP) procedure 
• Ownership, management, execution and reporting of high-level validation documentation, including but not limited to Test Method Validations, PFMEAs, Installation Qualifications, Operational Qualifications, Process Qualifications 
• Execution of Statistical Analysis and process capability assessments to support validation activities. 
• Experience in Microsoft Project and Minitab applications for use in NPI projects
• Performs other related duties, as assigned.

Key Requirements for the role

Reporting to the NPI Program Manager, the successful candidate must have a track record of success in a development and manufacturing environment within the medical device industry, a degree in Engineering or related field and minimum of 7 years’ experience in a medical device engineering role. Candidate must be highly motivated and passionate about developing new products with strong documentation, oral, and interpersonal communication skills required. The individual must be proficient in Medical Device production and process development principles with a strong knowledge of Quality System compliance requirements. This candidate must possess strong analytical skills and problem-solving skills. Project management experience is desirable.

U.S. Applicants: EOE/AA Disability/Veteran