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MSD
MSD
H1B Visa SponsorBiotechnologyHealthcareLogistics

MSD is a global biopharmaceutical company advancing medicines and vaccines for major health challenges, including cancer, infectious diseases, cardiovascular and metabolic conditions, and prevention-focused care. Known as Merck & Co., Inc. in the United States, Canada, and Puerto Rico, MSD combines scientific research with development and commercial expertise to bring healthcare solutions to people and animals.

Its work spans Human Health, Animal Health, and Research & Development, creating opportunities for professionals across scientific, clinical, commercial, operational, and corporate teams. With activities in regions around the world, MSD’s careers reflect its focus on research, collaboration, inclusion, and responsible progress in global health.

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Senior Medical Device Technical Operations Engineer

Lead engineering work for medical devices and combination products, from design transfer through commercialization. Guide technical operations while meeting quality and regulatory objectives.

USUnited StatesNJNew JerseyPAPennsylvania
$117,000 – $184,200 / year
HybridFull-timeSeniorEnglish RequiredFull-stack EngineerSoftware Engineer
Assembly

Description

  • Strengthen engineering capabilities for medical devices and combination products
  • Oversee internal and external manufacturing across development, scale-up, commercialization, and design transfer
  • Provide technical expertise on device components, combination products, and related processes
  • Contribute to global commercialization and technology transfer
  • Improve product robustness for sustained launches while meeting business, quality, and regulatory objectives
  • Use design controls, transfer methods, control strategies, device risk management, and design verification testing
  • Support global manufacturing of components and combination products at internal and external sites
  • Spot early signs of issues, investigate root causes, and develop solutions
  • Establish design engineering practices for medical devices and combination products throughout development and lifecycle management
  • Improve product design and manufacturing with engineering best practices and tools
  • Respond to regulatory agency questions and support pre-approval and other regulatory inspections
  • Plan and carry out strategic technology transfers and problem-solving efforts
  • Lead teams in late-stage development and work with internal and external partners
  • Develop strategic relationships with manufacturing sites and partner groups
  • Ensure work complies with safety, quality, regulatory, divisional, and local-site requirements

Requirements

  • Bachelor’s degree in mechanical engineering, biomedical engineering, or a related technical discipline is required
  • A master’s degree or PhD is preferred
  • At least five years of engineering experience in pharmaceuticals, biologics, medical devices, or combination products
  • At least two years of experience supporting commercial manufacturing
  • Expertise in design controls, risk analysis, control strategies, design verification testing, and process validation
  • Strong knowledge of quality management systems and regulatory compliance
  • Technical experience with injection molding, automation, complex assembly, and packaging operations for medical device or combination product components
  • Direct experience with autoinjectors, ophthalmic products, or inhalation products is strongly preferred
  • Proficiency with ISO 13485, ISO 14971:2019, and other relevant quality management systems
  • Must reside in the United States or Puerto Rico
  • Must be willing to travel 10%
  • Visa sponsorship is not available
  • A valid driver’s license is not required

Benefits

  • Annual bonus and long-term incentive, where applicable
  • Medical, dental, vision, and other insurance coverage for employees and their families
  • Retirement benefits, including a 401(k)
  • Paid holidays
  • Vacation
  • Compassionate and sick leave
  • Hybrid work arrangement
  • Relocation is not required

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