Senior Device Development Engineer

The RFT Group; Ireland; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

The RFT Group is seeking an experienced Senior Device Development Engineer to guide end-to-end development of proprietary drug delivery medical devices and combination products from concept through scale-up to commercial manufacture. This is a full-time 12-month fixed-term contract based in Ireland or the UK with flexible home-office work and weekly on-site presence.

Reporting to the Director of Device Development, you will lead external partner collaborations, oversee design

Qualifications

• 10+ years' experience in medical device or combination product development.
• Bachelor's or Master's in Science or Engineering.
• Knowledge of EU MDR 2017/745, ISO 13485, ISO 14971; 21 CFR Part 820 desirable.
• Experience in design verification/validation and human factors (IEC 62366-1) desirable.
• Proven ability to work with internal cross-functional teams and external vendors/CDMOs/CMOs.
• Excellent English written and verbal communication.

Responsibilities

• Lead collaboration and technical management oversight of external development and manufacturing partners.
• Provide design verification, validation, and test method development leadership.
• Own technical direction across development programs, ensuring robust solutions.
• Align user needs and stakeholder requirements with regulatory expectations.
• Coordinate cross-functional teams and external partners to deliver products.

Skills

Electromechanical devices

Regulatory knowledge

Project management

Verbal & written English

Vendor / CDMO management

Education

Bachelor’s or Master’s in Science/Engineering

Job description

We now seek an experienced Senior Device Development Engineer to support supports the design and development of proprietary drug delivery medical devices and combination products, with responsibilities for taking early-stage combination drug device product through product development cycle i.e. design to scale-up to commercial high-volume manufacture.

This is a full-time 12-month fixed term contract role with potential to extend; in an innovative, growing Biotech company.

Reporting to the Director of Device Development, the successful candidate will lead collaboration and technical management oversight of external development and manufacturing partners, focusing on engineering design, verification, validation and technical leadership for the product. Through management and technical oversight of external development partners, the role ensures user and stakeholder needs are accurately defined and that robust engineering solutions are developed to deliver safe and effective products to market.

The successful candidate will work across several development programmes and external partners. It provides technical ownership of specific areas, such as design verification and combination product performance, or human factors and labelling, so that methods, requirements and evidence stay consistent.

The ideal candidate will be at Senior Product Development Engineer, with end-to-end product development to commercial high-volume manufacture, with oversight and management of global vendors / CDMOs.

This hire will be based in Ireland or the UK and have flexibility to work majority of time from their home office, with ideally one day per week on site. Some travel as required, to CDMO/CMO sites to fulfil person in plant responsibilities during critical stages of the development program.

Flexibility and adaptability are important wrt. changing priorities and program deliverables, collaborating with cross-functional development teams both internally (design engineers, device and drug manufacturing, regulatory, marketing, clinicians, etc.) and externally (third parties, CDMOs/CMOs, etc) to bring innovative products to market.

Requirements for Senior Device Development Engineer:

• Bachelor’s Degree or Master’s Degree qualification in Science, Engineering or a related field.
• 10+ years’ related experience in medical device or combination product development.
• Technical expertise in electromechanical medical devices and knowledge of emerging technologies.
• Knowledge of EU MDR 2017/745, ISO 13485, 21 CFR Part 820 and ISO 14971.
• Industry experience of relevant regulations and guidelines for inhalation medical devices and combination products is required.
• Experience in design verification and validation, test method development, and/or human factors and usability engineering (IEC 62366-1) is highly desirable.
• Proven experience interacting with internal cross functional teams and externally with third party service providers / vendors / CDMOs / CMOs required.
• Excellent written, verbal and presentation skills in English.
• Strong planning, organisational, problem-solving, analytical and decision‑making skills.