Medical Device Development - Consultant

Astro Studios, Inc.; Pennsylvania; On-site; USD 80,000 - 140,000; Full time

Job summary

An established industry player is seeking a highly skilled consultant to join their Life Sciences consulting team. This role focuses on the development of innovative medical devices, requiring a deep understanding of regulatory and quality standards. The ideal candidate will lead complex projects, ensuring compliance while driving innovation in MedTech. Join a diverse team of experts dedicated to creating impactful solutions in health and life sciences. If you're passionate about improving lives through technology and want to work in a collaborative environment, this opportunity is perfect for you.

Benefits

Private Healthcare

25 Days Annual Leave

Generous Pension Scheme

Community Involvement Opportunities

Performance-Based Bonus

Share Ownership

Tax Efficient Benefits

Qualifications

• 5+ years in MedTech with a focus on medical device development.
• Strong knowledge of regulatory frameworks and compliance.
• Experience in leading complex, multidisciplinary projects.

Responsibilities

• Lead multidisciplinary teams for medical and drug delivery device development.
• Ensure compliance with global regulatory requirements.
• Manage multiple projects while aligning with business needs.

Skills

Project Management

Regulatory Compliance

Problem-Solving

Technical Leadership

Cross-Functional Collaboration

Education

Engineering Degree

Biomedical Engineering

Mechanical Engineering

Electrical Engineering

Tools

ISO 13485

IEC 62304

FDA Regulations

MDR/IVDR

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.

We are seeking a highly skilled consultant with experience in medical device development to join our Life Sciences consulting team. This role focuses on the development of medical devices, including 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 while driving innovation in MedTech and pharmaceutical product development.

Key Responsibilities:

Technical Leadership

1. Act as a systems engineering leader, bringing together multi-disciplinary teams - design, mechanical, electrical, software, quality and regulatory - to develop complex medical and drug delivery devices.
2. Define system architecture, ensuring alignment with safety, usability, and regulatory requirements (ISO 13485, IEC 62304, ISO 14971, FDA 21 CFR 4/ 820).
3. Oversee technical project management, ensuring clear requirements, risk management, and seamless integration of cross-functional expertise.
4. Lead end-to-end product development, from user needs analysis and design to development, verification, validation, and regulatory approval.

Regulatory & Quality Compliance for Medical/ Drug Delivery Devices

1. Provide expertise on global regulatory requirements for medical/ drug delivery devices, ensuring compliance with FDA, EMA, MHRA, MDR/IVDR, and ISO standards.
2. Lead risk management activities (ISO 14971), ensuring safety and efficacy through robust design and process controls.
3. Guide processes for hardware, software, and AI-driven medical devices, including compliance with IEC 62304 (medical software lifecycle processes) and IEC 62366 (usability engineering for medical devices).
4. Develop and optimise Quality Management Systems (QMS) to streamline compliance and lifecycle management.

Stakeholder & Client Engagement

1. Work closely with clients, R&D teams, business stakeholders, and regulatory bodies to align project goals with industry requirements.
2. Facilitate cross-functional collaboration, ensuring smooth integration between engineering, quality, and regulatory disciplines.
3. 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

1. Engineering background (systems, biomedical, mechanical, electrical, software, or related field).
2. At least five years' experience in MedTech, pharmaceuticals, or life sciences, with a strong track record in medical device development and technical project management.
3. Deep expertise in regulatory frameworks (FDA, EMA, MDR/IVDR, ISO 13485, IEC 62304, ISO 14971, GAMP, 21 CFR 4/ 820).
4. Experience leading complex, multidisciplinary product development projects, integrating hardware, software, and regulatory expertise.
5. Strong problem-solving skills and the ability to drive technical decision-making in a highly regulated environment.
6. Ability to manage multiple concurrent projects, ensuring alignment with business and regulatory needs.

We know the skill-gap and ‘somewhat 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.

Apply today by completing our online application

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:

1. Health and lifestyle perks accompanying private healthcare for you and your family
2. 25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
3. Generous company pension scheme
4. Opportunity to get involved with community and charity-based initiatives
5. Annual performance-based bonus
6. PA share ownership
7. 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 other 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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