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Amgen

Makes biotech medicines for serious illnesses

Device Engineering Senior Engineer

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeCambridge, MA, USA

About the Job

Requirements

  • A doctorate degree, or a master's degree and 2 years of engineering experience, or a bachelor's degree and 4 years of engineering experience, or an associate's degree and 8 years of engineering experience, or a high school diploma or GED and 10 years of engineering experience.
  • Fluency in English.
  • Five or more years of progressive experience as a mechanical engineer is preferred.
  • Three or more years of experience developing medical devices, ideally Class II and Class III, is preferred.
  • Experience in mechanical engineering disciplines and tools, with hands-on work in at least one Design for Robustness discipline—Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, Design for Assembly (DFA), or Design for Manufacturing (DFM)—and preferably exposure to several is preferred.
  • Experience in drug/device combination product design and development is preferred.
  • Technical understanding of manufacturing processes, including injection molding and assembly processes, is preferred.
  • Technical understanding of drawings and design documentation is preferred.
  • Understanding of documentation flow for Good Manufacturing Practice (GMP) deliverables is preferred.
  • Knowledge of the Quality Management System, Quality Management Policy, and applicable laws and regulations as they apply to this job type or position is preferred.
  • Familiarity with U.S. Good Manufacturing Practices (21 CFR 820), Quality Management (ISO 13485), needle-based injection systems for medical use (ISO 11608), and Risk Management (ISO 14971) is preferred.
  • Strong interpersonal skills are preferred.
  • Ability to work within cross-cultural project teams is preferred.
  • Systematic problem-solving and solution development when presented with conflicting needs and technical issues are preferred.
  • Strong communication and presentation skills are preferred.

Responsibilities

  • Independently execute tasks within one or more Design for Robustness disciplines: Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, Design for Assembly (DFA), or Design for Manufacturing (DFM).
  • Provide technical recommendations to improve design performance, reduce sensitivity to variation, and enhance overall system robustness.
  • Collaborate across robustness disciplines to identify risks and mitigations, opportunities, and best trade-off solutions.
  • Contribute to continuous improvement of robustness disciplines and tools by identifying gaps, proposing improvements, and supporting implementation under governance frameworks.
  • Interface effectively with discipline subject-matter experts and incorporate their guidance while maintaining ownership of robustness execution within the assigned scope.
  • Drive structured problem-solving and root cause analysis for design, test, and field performance issues, ensuring robust corrective solutions.
  • Collaborate closely with manufacturing, quality, and suppliers to improve product robustness and reduce variation-driven failures.
  • Apply systems-level thinking to anticipate how design decisions affect downstream manufacturability and performance.

Desired Qualifications

  • Five or more years of progressive experience as a mechanical engineer.
  • Three or more years of experience developing medical devices, ideally Class II and Class III.
  • Experience in mechanical engineering disciplines and tools, with hands-on work in at least one Design for Robustness discipline—Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, Design for Assembly (DFA), or Design for Manufacturing (DFM)—and preferably exposure to several.
  • Experience in drug/device combination product design and development.
  • Technical understanding of manufacturing processes, including injection molding and assembly processes.
  • Technical understanding of drawings and design documentation.
  • Understanding of documentation flow for Good Manufacturing Practice (GMP) deliverables.
  • Knowledge of the Quality Management System, Quality Management Policy, and applicable laws and regulations as they apply to this job type or position.
  • Familiarity with U.S. Good Manufacturing Practices (21 CFR 820), Quality Management (ISO 13485), needle-based injection systems for medical use (ISO 11608), and Risk Management (ISO 14971).
  • Strong interpersonal skills.
  • Ability to work within cross-cultural project teams.
  • Systematic problem-solving and solution development when presented with conflicting needs and technical issues.
  • Strong communication and presentation skills.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size
10,001+
Company stage
IPO
Headquarters
Thousand Oaks, CA
Founded
1980

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