Medical device engineer Work, Jobs in Maulden, Bdf (with Salaries)

Medical Device Regulatory and Quality Consultant
PA Consulting —Melbourn
- Full-time
- Annual leave
Quality Engineer - St Neots
OSI Systems, Inc —St. Neots
- Full-time
- Continuous improvement
- Quality control
- Computer skills
Control Systems Engineer
Johnson Matthey —Royston
- Full-time
- Programmable logic controllers
- Communication skills
Medical Device Engineer
PA Consulting —Melbourn
- Full-time
- Engineering
- Leadership
- Communication skills
- Annual leave
Remote Support Engineer
Frossell Recruitment —Milton Keynes
- £37,500 a year
- Full-time
- Schematics
- Engineering
- In-person
- Employee assistance programme
- Employee discount
Quick apply
Quality Engineer - St Neots
OSIE —St. Neots
- Continuous improvement
- Quality control
- Computer skills
Field Service Engineer (UKI)
Cutera, Inc. —Letchworth
- £50,000 - £60,000 a year
- Full-time
- English
- Bachelor's degree
- Travel
Quick apply
Senior Robotics & Lab Automation Engineer
Sartorius —Royston
- Full-time
- Hybrid work
- Doctoral degree
- Master's degree
- Scripting
- Free parking
- Annual leave
Desktop Support Engineer
Getronics —Wellingborough
- £30,000 - £35,000 a year
- Full-time
- Microsoft Office
- Analysis skills
- In-person
- Health & wellbeing programme
- Annual leave
Quick apply
Senior Embedded Design Engineer (Open) No Recruiters
Ripcord Designs —Harpenden
- £55,000 - £65,000 a year
- Full-time
- Hybrid work
- Computer Science
- English
- Communication skills
6d
3rd Line Service Desk Engineer
Bechtle UK —West Hunsbury
- £45,000 - £55,000 a year
- Full-time
- Windows
- Mentoring
- Organisational skills
- Health & wellbeing programme
- Annual leave
Quick apply
14d
QA Lead Engineer
Motorola Solutions —Ware
- Full-time
- Engineering
- Bachelor's degree
- No degree
- Employee stock purchase plan
- Employee assistance programme
13d
Embedded Software Engineer
PA Consulting —Melbourn
- Full-time
- Engineering
- Communication skills
- Annual leave
Quick apply
Installation Technician
ACT Response LTD —Tring
- £36,700 - £42,000 a year
- Overtime
- Customer service
- Power tools
- Hand tools
- Annual leave
- Employee discount
Quick apply
Senior Electronics Design Engineer (OPEN) No Recruiters
Ripcord Designs —Harpenden
- £55,000 - £65,000 a year
- Full-time
- Hybrid work
- Computer Science
- Communication skills
- Python
6d
SMT Operator
OSI Systems, Inc —St. Neots
- Full-time
- Schematics
- Assembly
- Quality control
4d
Senior Manufacturing Engineer
Cytiva —Stevenage
- Full-time
- Remote
- Engineering
- Bachelor's degree
- Continuous improvement
- Annual leave
Engineer Surveyor - Cat 2 - Stevenage
HSB —Stevenage
- From £44,750 a year
- Overtime
- Communication skills
- School
- Time management
- Annual leave
- Employee assistance programme
13d
SMT Operator
OSIE —St. Neots
- Schematics
- Assembly
- Quality control
4d
Software Engineer – Embedded & PC Applications
Sagentia Innovation —Cambridge
- Full-time
- Computer Science
- Engineering
- Master's degree
- Employee assistance programme
Quick apply
8d

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Medical Device Regulatory and Quality Consultant

PA Consulting -
Melbourn

Apply Now

Job details

Full-time

Benefits

Cycle to work scheme
Annual leave
Company pension
Private medical insurance

Qualifications

Technical troubleshooting
GAMP
Stakeholder collaboration
Client engagement
Stakeholder liaison
Quality management
Product development
Decision making
Risk management
Multidisciplinary collaboration
Cross-functional collaboration
Project management experience
ISO 13485
FDA regulations

Full job description

We believe in the power of ingenuity to build a positive human future.

As strategies, technologies, and innovation collide, we create opportunity from complexity.

Our diverse teams of experts combine innovative thinking and breakthrough technologies to progress further, faster. Our clients adapt and transform, and together we achieve enduring results.

We are over 4,000 strategists, innovators, designers, consultants, digital experts, scientists, engineers, and technologists. And we have deep expertise in consumer and manufacturing, defence and security, energy and utilities, financial services, government and public services, health and life sciences, and transport.

Our teams operate globally from offices across the UK, Ireland, US, Nordics, and Netherlands.

PA. Bringing Ingenuity to Life.

Job description

We are seeking a highly skilled consultant with experience in medical device and/or combination product Quality and Regulatory processes to join our Healthcare & Life Sciences (HLS) consulting team. This role focuses on advising clients on the regulatory, Quality and compliance aspects of medical devices, through a strong understanding of regulatory and quality requirements for medical devices, software as a medical device (SaMD), and/or combination products. The ideal candidate will have experience leading complex technical projects, integrating multidisciplinary expertise, and ensuring regulatory and quality compliance in innovative MedTech and pharmaceutical product developments.

Key Responsibilities:

Regulatory & Quality Compliance for Medical Devices and Combination Products

Provide expertise on global regulatory requirements for medical devices and combination products ensuring compliance with FDA, EMA, MHRA, MDR/IVDR, and ISO standards.
Guide processes for hardware, software, and AI-driven medical device development to ensure compliance with applicable regulatory standards and guidance, including ISO 13485, ISO 14971, IEC 62304, and related standards and guidance for AI-driven medical technologies.
Advise cross-functional teams of designers, mechanical, electrical, software and usability engineers on requirements and best practices for regulatory and quality compliance.
Ensure requirements traceability from user needs through design, development, verification, and validation
Lead risk management activities in accordance with ISO 14971, ensuring safety and efficacy through robust design and process controls.
Develop and optimise clients’ Quality Management Systems (QMS) to streamline compliance and lifecycle management

Stakeholder & Client Engagement

Work closely with clients’ R&D teams, business stakeholders, and notified bodies to align project goals with industry requirements.
Facilitate cross-functional collaboration, ensuring smooth integration between engineering, quality, and regulatory disciplines.
Translate complex technical and regulatory requirements into actionable development strategies for medical technologies.

Flexible working - We are guided by our client work and needs; however, you have autonomy to manage your time and diary to suit your work/life balance.

Qualifications

The ideal candidate will have:
A technical background in Engineering (systems, biomedical, mechanical, electrical, software, or related field) or Applied Science (physics, chemistry, biology, materials science, etc.).
Demonstrated prior direct experience in the design, development, or testing of medical devices and/or combination products.
At least five years' experience in MedTech, pharmaceuticals, or life sciences, with a strong track record in regulated product development.
Deep expertise in regulatory frameworks (FDA, EMA, MDR/IVDR, ISO 13485, IEC 62304, ISO 14971, GAMP, 21 CFR 4/ 820).
Proven ability to work cross-functionally with engineering, quality, and regulatory teams, contributing practical insights from previous technical roles.
Strong problem-solving skills, troubleshooting expertise and the ability to drive technical decision-making in a highly regulated environment ensuring alignment with business and regulatory needs.
Ability to manage multiple concurrent projects.

We know the skill-gap and the ‘need to tick every box’ can get in the way of meeting brilliant candidates, so please don’t hesitate to apply – we’d love to hear from you.

Additional information

Life At PA encompasses our peoples' experience at PA. It's about how we enrich peoples’ working lives by giving them access to unique people and growth opportunities and purpose led meaningful work.

We believe diversity fuels ingenuity. Diversity of thought brings exciting perspectives; diversity of experience brings a wealth of knowledge, and diversity of skills brings the tools we need. When we bring people together with diverse backgrounds, identities, and minds, embracing that difference through an inclusive culture where our people thrive; we unleash the power of diversity – bringing ingenuity to life.

We are dedicated to supporting the physical, emotional, social and financial well-being of our people. Check out some of our extensive benefits:

Health and lifestyle perks accompanying private healthcare for you and your family
25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
Generous company pension scheme
Opportunity to get involved with community and charity-based initiatives
Annual performance-based bonus
PA share ownership
Tax efficient benefits (cycle to work, give as you earn)

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, or by any other range of human difference brought about by identity and experience. We are on a journey towards ensuring our workforce is diverse at all levels and that our firm is representative of the world around us. 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.

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medical device engineer jobs in maulden, bdf

Medical Device Regulatory and Quality Consultant

Quality Engineer - St Neots

Control Systems Engineer