Senior NPI Engineer

freudenberg; Carrick-on-Shannon; On-site; EUR 70,000 - 110,000; Full time

Job summary

VistaMed Ltd. seeks a senior engineering professional to lead complex projects in medical device transfer to manufacturing. You will work with technical leads and cross-functional teams to develop transfer roadmaps, timelines, and robust processes.

The role emphasizes solving complex problems, training junior staff, and maintaining strict quality and regulatory standards across projects.

Qualifications

• Third level engineering qualification in Polymer, Biomedical, Mechanical, Design.
• Minimum Bachelor's Degree in Science/Technology/Engineering discipline.
• Senior role may exist with at least 4 years of experience.
• Experience in Project Management for new product introductions.

Responsibilities

• Solve complex problems and provide new perspectives on solutions.
• Lead as a specialist within own discipline and train juniors.
• Coordinate transfer of product designs into qualified manufacturing processes.
• Present regular project status updates to customers and business.
• Ensure quality, regulatory and timeline adherence during stage gates.

Skills

Complex problem solving

Specialist expertise

Cross-functional collaboration

Independent worker

Education

Engineering degree (Polymer/Biomedical/Mechanical/Design)

Job description

Empowering people, creating technology.

Responsibilities

This involves but is not limited to:

• Solving complex problems or problems where precedent does not exist and takes a new perspective on existing solutions
• Serves as a specialist or expert within own job discipline
• Fosters strong collaborative partnerships with technical leads and cross-functional team members to develop accurate transfer roadmaps and timeline
• Provides regular project status update-presentations to customers and the business
• Drives strong adherence to all stage gate reviews for quality, regulatory and business purposes.
• Coordinate and manage teams in meeting internal and external (customer) quality, timeline and budget commitment in transferring product and packaging designs into fully qualified commercial manufacturing processes
• Contributes to products/services or process improvements or uses best practices and knowledge of internal or external business issues to improve products/services or processes
• Works independently or with minimal guidance
• Has in-depth working knowledge in own discipline and good knowledge of related disciplines
• Often leads projects or project steps within a broader project or has accountability for on-going activities or objectives
• Formally trains junior staff or acts as a resource for colleagues with less experience
• Requires in-depth conceptual and practical knowledge of theories, practices and procedures in own job discipline and moderate knowledge in related job disciplines
• Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market
• Acts as a resource for colleagues with less experience
• Solves complex problems
• Takes a new perspective on existing solutions and exercises judgement based on the analysis of multiple sources of information
• Impacts a range of customer, operational, project or service activities within own team and other related teams; works within broad guidelines and policies
• Explains difficult or sensitive information; works to build consensus in complex situations

Qualifications

• Third level engineering qualification in Polymer, Biomedical, Mechanical, Design; Minimum Bachelor's Degree in a Science / Technology / Engineering related discipline (Mechanical, Manufacturing, Automation or equivalent)
• A Senior position may exist with a minimum of 4 years experience.
• Experience in Project Management regarding new product introduction, preferably in a Medical Device environment.
• Preferably highly competent in manufacturing processes used for manufacturing catheters etc, including extrusion, moulding, balloon forming, braiding, packaging and other assembly techniques.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

VistaMed Ltd.