Product Development Engineer

SteriPack Ireland; Mullingar; On-site; EUR 55,000 - 75,000; Full time

Job summary

Sterimed, a global leader in sterilization packaging solutions, seeks engineers to design and develop innovative packaging products at Steripack Ireland. The role involves creating test methods, supporting validations, and delivering prototype samples for the sales team.

The successful candidate will have 2–5 years in medical devices, strong problem solving, and experience with IQ/OQ/PQ protocols and statistical analysis. Join a fast-growing, regulated environment at Steripack Ireland.

Qualifications

• Bachelor’s or advanced degree in Engineering.
• 2–5 years’ experience in product development in medical devices.
• Experience with continuous improvement to improve efficiencies and costs.
• Knowledge of statistical analysis and statistical process control.
• Experience in medical devices or other regulated industries.
• IQ, OQ, PQ validations/protocols knowledge for medical production lines.

Responsibilities

• Develop conceptualization and design of new product concepts.
• Prepare engineering documents, raw material specs, and finished goods specs; conduct reviews.
• Develop product/process specifications including IQ/OQ/PQ and risk management.
• Create test methods and protocols for evaluation.
• Support process validation activities and prototype manufacturing for sales.
• Provide technical support to accelerate proposal closures.

Skills

Problem solving

Curiosity

Independent worker

Team collaboration

Education

Bachelor’s or advanced degree in Engineering

Job description

With 1,700 employees and 14 factories across 3 continents, STERIMED is the world's leading manufacturer of materials and packaging systems for the sterilization of medical devices. Sterimed develops, produces, converts, and markets various solutions such as bacterial barrier substrates and preformed sterilization packaging, serving both hospitals and medical device manufacturers.

All the entities within the group work together in synergy to deliver reliable and innovative solutions, while the main site in France concentrates the industrial expertise and serves as the group’s innovation center.

With a strong entrepreneurial DNA, Sterimed has experienced rapid growth since its creation in 2016 through both organic development and external expansion: the size of the group has been multiplied by 4.5, and 10 acquisitions have been completed since 2017.

Steripack Ireland, a subsidiary acquired by the Sterimed Group in 2023, exemplifies this dynamic growth. Operating from a brand-new, state-of-the-art facility, Steripack is a partner of choice for innovative healthcare packaging solutions. The company offers end-to-end expertise, from concept to finished product, and delivers tailored, market-leading solutions to meet the most complex customer requirements.

POSITION OVERVIEW

The role will be responsible for supporting the design and development of innovative packaging solutions and Contract Pack introductions at Steripack Ireland. Primary responsibilities will include the development of test methods, supporting process validation activities, execution of material trials, and the manufacture of prototype samples for the sales team

MAIN RESPONSIBILITIES

• Develop conceptualization and design of new product concepts
• Will have a responsibility to deliver engineering documents, raw material specifications, and finished good specifications, conduct engineering reviews and may be involved with implementation oversight including equipment, material validations and processing protocol development
• Develop specifications for products and processes, including URS, FAT, SAT, IQ, OQ, PQ, Risk Management and documentation required for validation and verification of products and processes.
• Develop test methods and protocols for execution.
• Builds the process capability to meet the quality standards required for the design and manufacture of products
• Provide training to technical personnel
• Analyses, designs, set-up, produce and develops design and manufacturing solutions to engineering challenges associated with manufacturing technologies
• Provide customer support, including technical support and direct support to accelerate the closure of sales proposals.

QUALIFICATIONS, KNOWLEDGE, SKILLS, EXPERIENCE

• Bachelor’s or advanced degree in Engineering
• 2 to 5 years’ experience in product development within medical devices
• Experience with continuous improvement efforts to improve efficiencies and costs
• A demonstrated ability to work independently or as part of a team to complete projects within required timeframes
• Knowledge and experience in statistical analysis and statistical process control
• Previous experience in medical device or other regulated industries
• Expertise in developing projects with ISO16890, EN779. EN14683, EN149
• Knowledge and aptitude of IQ, OQ, PQ validations/protocols for medical production lines.

PERSON SPECIFICATION AND CORE COMPETENCIES

• A demonstrated ability to work independently or as part of a team to complete projects within required timeframes
• Strong problems solving skills
• Uses curiosity to investigate and explore technical issues

Sterimed is committed to creating an inclusive and accessible work environment. Feel free to let us know about any accommodations you may need to participate in the recruitment process.