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Medical Device Development Jobs in Pennsylvania (NOW HIRING)

Bayer

$77K - $116K/yr

R&D Electrical Engineer - Medical Device - Indianola, PA R&D Electrical Engineer - Medical Device - Indianola, PA PURPOSE R&D Electrical Engineer - Medical Device isResponsible for the design ...

Globus Medical

Senior Software Engineer

Audubon, PA · On-site

$123K - $162K/yr

This role requires strong technical leadership, a deep understanding of software development best practices, and the ability to thrive in a highly regulated medical device environment. The ...

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Medical Device Development information

What are the key skills and qualifications needed to thrive in medical device development, and why are they important?

To thrive in Medical Device Development, you need expertise in engineering or life sciences, a solid understanding of regulatory requirements, and often an advanced degree such as a master's or Ph.D. in a relevant field. Familiarity with CAD software, prototyping tools, and knowledge of FDA or ISO regulatory standards is typically required. Strong problem-solving abilities, collaboration, and effective communication distinguish top professionals in this field. These skills ensure the development of safe, innovative, and compliant medical devices that meet both user needs and regulatory standards.

What is the difference between Medical Device Development vs Medical Device Quality Assurance?

AspectMedical Device DevelopmentMedical Device Quality Assurance
CredentialsEngineering degrees, certifications like RAPS or regulatory trainingQuality certifications, ISO 13485, regulatory compliance training
Work EnvironmentDesign labs, R&D teams, product development settingsManufacturing sites, quality control labs, compliance departments
Industry UsageDesigning and creating new medical devicesEnsuring devices meet quality and regulatory standards

Medical Device Development focuses on designing and creating new medical devices, involving engineering and product innovation. Medical Device Quality Assurance ensures these devices meet safety, quality, and regulatory standards through testing and compliance processes. Both roles are essential in the medical device industry but serve different functions in the product lifecycle.

What are some common challenges faced by professionals in medical device development, and how can they be addressed?

Professionals in medical device development frequently encounter challenges such as navigating complex regulatory requirements, ensuring product safety and efficacy, and managing cross-functional collaboration between engineering, clinical, and regulatory teams. Addressing these challenges requires staying updated on evolving regulations, fostering open communication among diverse team members, and implementing robust quality control processes. Proactively engaging with regulatory bodies and regularly reviewing project milestones can help streamline development and reduce the risk of costly delays.

What is medical device development?

Medical device development is the process of designing, creating, testing, and bringing medical devices to market. This process involves multiple stages, including concept development, prototyping, preclinical and clinical testing, regulatory approval, and manufacturing. The goal is to ensure that new devices are safe, effective, and meet regulatory standards before they are used by healthcare professionals or patients. Teams in medical device development often include engineers, scientists, regulatory specialists, and quality assurance professionals.

What cities in Pennsylvania are hiring for Medical Device Development jobs?

Cities in Pennsylvania with the most Medical Device Development job openings:

Medical Device Development jobs near you
Infographic showing various Medical Device Development job openings in Pennsylvania as of August 2026, with employment types broken down into 1% As Needed, 73% Full Time, 20% Part Time, 5% Contract, and 1% Nights. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Sr. Specialist, Regulatory Project Management

West Pharmaceutical Services

Exton, PA • Hybrid

Full-time

Re-posted 2 days ago

West Pharmaceutical Services rating

8.5

Company rating: 8.5 out of 10

Based on 32 frontline employees who took The Breakroom Quiz

12th of 119 rated packaging manufacturers

Job description

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. 

Who We Are:

At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary
  • The Senior Specialist, Regulatory Project Management is responsible for leading regulatory project execution for West's global portfolio of medical devices, combination products, software-enabled devices/SaMDs, and packaging components.
  • This role partners with the Regulatory Affairs Lead, Cross-functional SMEs, and external stakeholders to drive regulatory deliverables across development, submission, approval, and post-market lifecycle phases.
  • The successful candidate will bring a strong combination of medical device technical understanding, knowledge of global regulatory frameworks, and project management capability to support timely, compliant regulatory submissions and lifecycle activities.
  • The role supports FDA premarket submissions (510(k)), EU MDR Technical Documentation, Master Files (DMF/MAF), change notifications, information request responses, post-approval commitments, and post-market regulatory deliverables.
Essential Duties and Responsibilities
  • As Regulatory Project Management, lead execution for assigned medical device, combination product, SaMD/software-enabled device, and packaging component programs across the product lifecycle.
  • Develop and manage integrated regulatory project plans, timelines, dashboards, risk/issue logs, decision trackers, and escalation pathways to support timely execution of deliverables.
  • Monitor project milestones, dependencies, resource needs, and risks; proactively escalate issues to leadership with recommended mitigation actions.
  • Coordinate the preparation, review, approval, and submission of global regulatory filings, information request responses, change notifications, and post-market regulatory reports.
  • Partner with Regulatory Affairs Leads and cross-functional subject matter experts to align regulatory strategy, technical deliverables, submission readiness, and lifecycle planning.
  • Apply working knowledge of medical device design controls, risk management, verification and validation, usability/human factors, software documentation where applicable, labeling, and post-market requirements to identify technical or regulatory gaps.
  • Support interactions with health authorities, notified bodies, pharmaceutical partners, and other external stakeholders by coordinating documentation, responses, commitments, and follow-up actions.
  • Contribute to the continuous improvement of Regulatory Project Management tools, templates, procedures, metrics, and best practices.
Education & Experience
  • Education: Bachelor's degree in engineering, science, regulatory affairs, or a related technical discipline required; advanced degree preferred or equivalent experience 
  • Experience: Bachelor's degree with 5 years, or advanced degree with minimum 2 years relevant experience in medical device or combination product environments
Knowledge, Skills and Abilities
  • Experience supporting medical device development and/or regulatory activities across development, registration, and lifecycle management phases.
  • Working knowledge of applicable regulatory and quality frameworks, including FDA quality management system requirements (QSR/QMSR), EU MDR, ISO 13485, and other relevant global standards and guidance documents.
  • Demonstrated project management capability, including development and maintenance of integrated timelines, milestone tracking, risk and issue management, stakeholder communication, meeting facilitation, and escalation management.
  • Strong written and verbal communication skills, with the ability to distill complex technical, regulatory, and quality information for cross-functional teams and leadership.
  • Ability to work independently, manage competing priorities, and influence cross-functional stakeholders in a fast-paced, matrixed environment. 
  • Experience supporting successful FDA, EU MDR, or other global regulatory submissions and interactions with health authorities or notified bodies.
  • Experience with Class II and/or Class III medical devices, combination products, drug delivery systems, SaMD/software-enabled devices, or packaging components used with pharmaceutical or biologic products.
  • Familiarity with combination product requirements, device constituent part expectations, 21 CFR Part 4, software lifecycle documentation, cybersecurity, and usability/human factors requirements.
  • Working knowledge of design control principles, including technical documentation, risk management (ISO 14971), verification and validation, change control, and product lifecycle management.
  • Experience with medical device lifecycle activities, including change controls, complaints, CAPAs, post-market surveillance, technical documentation updates, and regulatory impact assessments.
  • Experience working with pharmaceutical partners, contract manufacturers, notified bodies, health authorities, or other external regulatory stakeholders.
  • Regulatory Affairs Certification, Project Management Professional certification, or equivalent certification preferred.
Travel Requirements
5%: Up to 13 business days per year
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
  • Ability to work independently in a fast-paced, dynamic environment with requirement to adhere to multiple time-sensitive commitments.  
  • Ability to comprehend principles of math, science, engineering, and medical device use. 
  • Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality. 
  • Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents. 
  • Ability to review, collate, describe, and summarize scientific and technical data. 
  • Ability to organize complex information and combine pieces of information to form general rules or conclusions. 
  • Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one. 
  • Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments. 
  • Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. 
  • Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. 
  • Ability to write and record data and information as required by procedures
  • Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

#LI-DJ1 #LI-HYBRID

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.

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