Medical Device Engineer

Astro Studios, Inc.; Wendy; On-site; GBP 90,000 - 130,000; Full time

Job summary

PA Global Innovation and Technology Centre in Melbourn, Hertfordshire, near Cambridge, seeks a Principal Consultant to lead drug-delivery and combination product development. You will provide senior mechanical engineering leadership across design, risk, usability and manufacturing, guiding projects and client relations.

The role emphasizes deep mechanical engineering judgement, regulatory knowledge, and the ability to influence decisions in complex development programmes with a global clientele.

Qualifications

• Senior engineer with substantial experience in medical device development.
• Experience in drug delivery devices or combination products.
• Strong leadership and client engagement.
• Knowledge of design controls, risk management, and testing.
• Experience with usability and human factors.

Responsibilities

• Lead complex drug delivery and combination product programmes from concept through to industrialisation.
• Provide senior technical leadership across engineering, usability, risk and manufacturability.
• Build trusted relationships with clients and internal teams.
• Shape strategy, direction and delivery on high-impact development programmes.

Skills

Mechanical design

Leadership

Project management

Client engagement

Regulated development

Education

Degree in Mechanical Engineering

Biomedical Engineering

Tools

Injection moulding

Design for manufacture

Requirements management

Job description

Global Innovation and Technology Centre, Back Lane, Melbourn, Hertfordshire, SG8 6DP, United Kingdom, Melbourn SG8 6DP, GB PA works with many of the world's most innovative pharmaceutical, medical device and life sciences companies. Based at our Global Technology and Innovation Centre near Cambridge, you will join a multidisciplinary team of scientists, engineers and designers developing products that improve patient outcomes and bring meaningful innovation to market. We are looking for an experienced engineering leader to shape and lead the development of drug delivery devices and combination products for leading pharmaceutical and medical technology clients. This role combines deep mechanical engineering expertise with strong technical, project and client leadership. What sets this role apart is the breadth of opportunity and autonomy it offers. At PA, you will have genuine scope to shape the work you do, deepen your expertise in the technologies and sectors that interest you most, and build a role that reflects your strengths and ambitions. For the right person, this is a rare opportunity to combine hands-on technical leadership with meaningful influence over projects, clients and career direction.

In this role, you will:

• lead complex drug delivery and combination product programmes from concept through to industrialisation;
• provide senior technical leadership across engineering, usability, risk and manufacturability;
• build trusted relationships with clients and internal teams; and
• shape strategy, direction and delivery on high-impact development programmes.

This role calls for a senior engineer with substantial experience in medical device development and a strong track record in drug delivery devices or combination products. We are looking for someone who combines deep mechanical engineering judgement with the credibility to lead teams, advise clients and make sound decisions in complex, regulated development programmes. The successful candidate will bring broad experience across device architecture, mechanism design, plastic moulded parts, actuation systems and design for manufacture, together with a practical understanding of assembly, sterilisation and industrialisation. They should also be confident in requirements management, structured risk reduction, and building the right test evidence at each stage of development to support robust decision-making.

Qualifications

As a Principal Consultant in the Mechanical Engineering team, you will:

• contribute hands-on to concept generation, mechanical design and technical reviews;
• define requirements, risk reduction plans, test strategies and supporting analysis;
• oversee project delivery, planning, financial control and technical risk management;
• support proposals, proposition development and follow-on business opportunities; and
• mentor colleagues, support team development and, over time, take on line management responsibility.

What you will bring

• a degree in Mechanical Engineering, Biomedical Engineering or a related discipline;
• significant experience in medical device and/or drug-device combination product development;
• a strong background in drug delivery devices and patient-facing combination products;
• expertise in mechanical design, actuation, injection moulding, tolerancing and design for manufacture;
• a good understanding of assembly, sterilisation and transfer towards manufacture;
• experience with requirements management, design controls, risk management, verification, validation and testing;
• a good understanding of usability and human factors;
• electro-mechanical experience as a beneficial additional strength;
• strong leadership, client engagement and project delivery skills; and
• clear written and verbal communication.

We're committed to advancing equality. We recruit, retain, reward and develop our people based solely on their abilities and contributions and without reference to their age, background, disability, genetic information, parental or family status, religion or belief, race, ethnicity, nationality, sex, sexual orientation, gender identity (or expression), political belief, veteran status, any other range of human difference brought about by identity and experience. We welcome applications from underrepresented groups.

Adjustments or accommodations - Should you need any adjustments or accommodations to the recruitment process, at either application or interview, please contact us.