Device Engineering Sr. Engineer
Amgen Inc. (IR)
- # **Career Category**Engineering## ## **Job Description**## Join Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.**Device Engineering Sr. Engineer****What you will do**Let’s do this. Let’s change the world. In this vital role you will join our Device Engineering group to support device development and engineering robustness. In support of Amgen’s mission to serve patients, the Device Engineering group at Amgen is a diverse team working to identify, develop, commercialize, and continuously improve drug delivery devices to optimize the patient experience.The Sr Engineer role is a cross-discipline execution role within the Design for Robustness framework. The role ensures consistent and structured application of robustness methodologies across mechanical design projects, integrating insights from device performance, sources of variation, load cases, materials, assembly, and manufacturing perspectives. While not serving as the formal discipline authority, the role strengthens project robustness execution and supports discipline SMEs under centralized governance.The Sr Engineer operates across disciplines and may execute within individual Design for Robustness disciplines; Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM, depending on project needs and targeted training.The position is based at our Amgen Massachusetts site with the possibility of a flexible working arrangement meeting business and private needs. You will be joining Amgen device development team consisting of 50+ engineers. This position will report to the Robustness Disciplines Lead.Responsibilities:* Independently execute tasks within one or more of the Design for Robustness disciplines; Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, 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 SMEs and incorporating guidance while maintaining ownership of robustness execution within 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 impact downstream manufacturability and performance.## **What we expect of you**We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual with these qualifications.**Basic Qualifications:**Doctorate degree OR Master’s degree and 2 years of Engineering experience OR Bachelor’s degree and 4 years of Engineering experience OR Associate’s degree and 8 years Engineering experience OR High school diploma / GED and 10 years of Engineering experience**Preferred Qualifications:*** 5+ years of progressive experience as a mechanical engineer.* 3+ years of experience within development of 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 disciplines; Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM, and preferably exposure to several.* Strong interpersonal skills* Ability to work within cross-cultural project teams* Systematic problem solver and solution developer also when presented with conflicting needs and technical issues.* Experience in drug/device combination product design and development* Technical understanding of manufacturing processes (injection molding, assembly processes)* Technical understanding of drawings and design documentation.* Understands documentation flow for GMP deliverables* Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position* Familiar with: US Good Manufacturing Practices - 21CFR820; Quality Management - ISO 13485; Needle-based injection systems for medical use - ISO 11608; Risk Management - ISO 14971.* Strong communication and presentation skills* Fluent in English language## **What you can expect of us**As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:* A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts* A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan* Stock-based long-term incentives* Award-winning time-off plans* Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.## Apply now and make a lasting impact with the Amgen team.## **careers.amgen.com**In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.## Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.## SponsorshipSponsorship for this role is not guaranteed.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity
- J-18808-Ljbffr Amgen Inc. (IR)
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Device Engineering Sr. Engineer in Cambridge, MA vacancy
$115.49k - $156.26k
...Career Category Engineering Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like... ...transform the lives of patients while transforming your career. Device Engineering Sr. Engineer What you will do Let's do this. Let's...SeniorFlexible hoursAmgen
Cambridge, MA1 day ago- Initial Therapeutics, Inc. is seeking a Device Engineering Sr. Engineer in Cambridge, Massachusetts. This role involves supporting device development and engineering robustness within the Device Engineering group. The right candidate will work on optimizing drug delivery...SeniorFlexible hours
- BioSpace is seeking a Device Engineering Sr. Engineer in Cambridge, MA. In this vital role, you will support device development with a focus on robustness methodologies. The successful candidate will work within various Design for Robustness disciplines and contribute to...SeniorFlexible hours
- Amgen Inc. (IR) in Cambridge, Massachusetts is looking for a Sr. Engineer in Device Engineering. This role involves cross-discipline execution within the Design for Robustness framework, ensuring robust product design and performance. Ideal candidates will have a strong...SeniorFlexible hours
- ...experienced professional in Boston, MA, to manage design control documentation for combination drug-device and biologic products. The ideal candidate has a B.S. or M.S. in Engineering and 510 years of experience within regulated medical device environments. Responsibilities...Senior
- Delve Inc. is seeking a Systems Engineer to lead product development in the medical device industry. This role involves guiding cross-functional teams, managing technical risks, and translating user needs into systems frameworks. The ideal candidate will have a Bachelor...Senior
- Location: Boston, MA or New Haven, CT What You Will Do This position will serve the role of Development Engineer within the Alexion Device Development organization. The candidate will act as the technical SME/project engineer supporting the development of combination...SeniorWork at office
$130k - $150k
...Trident Consulting is seeking a " Sr. Product Security Engineer (Medical Devices) " for one of our clients in " Burlington, MA (Hybrid - Onsite M/W/F required) " A global leader in business and technology services. Role: Sr. Product Security Engineer...SeniorFull timeContract workTrident Consulting
Burlington, MA2 days ago- Shoolin Inc in Boston is seeking a skilled engineer to design and develop medical device components and packaging systems. The role requires strong experience in product development and compliance with FDA, EU, and ISO standards. The ideal candidate holds a BS or MS in...SeniorContract work
$43.92 - $68.62 per hour
Capgemini is seeking a Senior Design Quality Engineer in Boston to ensure end-to-end design quality for Class II/III medical devices. You will oversee design controls and compliance throughout the product lifecycle, driving risk management and software quality assurance...SeniorRemote jobHourly pay- Planet Pharma Group is looking for a skilled Medical Device Development Engineer in Cambridge, Massachusetts. The position requires extensive experience in designing and developing drug delivery medical devices, focusing on mechanical design, testing, and regulatory compliance...Senior
- Planet Pharma is seeking a Principal Medical Device Engineer in Cambridge, Massachusetts. This strategic role involves leading the design and development of innovative medical devices and drug delivery technologies while ensuring compliance with regulatory standards. The...
$138k - $185k
## Senior Device Quality Engineering LeadApplyremote type: Hybridlocations: Cambridge, MAtime type: Full timeposted on: Posted Yesterdayjob requisition id: REQ23513**About This Role:**As the Senior Device Quality Engineering Lead, you will hold a pivotal role in ensuring...SeniorTemporary workLocal area- Planet Pharma Group seeks a Principal Medical Device Engineer located in Cambridge, Massachusetts. In this role, you will lead the design and development of innovative drug delivery technologies and medical devices while ensuring compliance with regulatory standards. With...
$126.6k - $189.8k
...therapies to patients as quickly as possible.The Product Development Engineering Senior Scientist focuses on combination product development,... ...Scientist will work closely with Research and Development, Device Quality Control, Device Quality Assurance, Process Development...SeniorSummer workFlexible hours$155k - $190k
...organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you'll be part of a team... ..., or technical leadership roles within regulated medical device environments Demonstrated experience defining and owning...Hourly payWork at officeFlexible hoursNova Biomedical
Watertown, MA4 days ago- ...Job Description Job Description Title: Principal Electrical Engineer- Medical Device/ Robotics Location: Onsite in Newton, Mass Duration: 6/12+ Months - Long term Skills: Testing PCBs and documenting, developing processes, senior level role- Must-have...
Tekhawks LLC
Newton, MA4 days ago $104.87k - $157.05k
...Sr Engineer, Application Location US-MA-Cambridge Company Canon U.S.A., Inc. Requisition ID 34522 Category Medical Device Position Type Full-Time Workstyle Full-Time On Site About the Role The...SeniorFull timeContract workFor contractorsFor subcontractorCasual workWork at officeLocal areaImmediate startRemote workMonday to FridayShift work1 day per weekCanon U.S.A., Inc.
Cambridge, MA1 day ago$130k - $185k
A health tech company is seeking a Senior Mechanical Engineer in Boston to lead the design and validation of next generation biometric wearable products. The role requires a proactive engineer with strong problem-solving skills and at least 4 years of experience in consumer...SeniorRelocation- Activ in Boston, MA is looking for a Senior Sustaining Engineer to lead manufacturing and engineering efforts. You will serve as the key technical contact with our contract manufacturer while ensuring product quality and compliance. The ideal candidate will have 6-10+...SeniorContract work
- A leading medical device firm in the U.S. is seeking a Mechanical Engineer with over 6 years of experience in mechanical design and development. The ideal candidate will have a Bachelor's degree in Mechanical Engineering and demonstrate expertise in CAD design, specifically...Senior
- A leading technology company in Wilmington seeks a Senior Mechanical Engineer with over 5 years' experience in medical device design and development. This position will lead engineering teams on projects involving mechanical design, compliance with FDA standards, and innovative...SeniorFlexible hours
- ...Job Title: Engineer, Drug Delivery Device Laboratory Support - (JP14438) Location: Cambridge, MA. 02138 Employment Type: Contract Business Unit: Combination Product Operations Duration: 1+ years (with likely extensions and/or conversion...Permanent employmentContract workInternshipFlexible hours
3 Key Consulting
Cambridge, MA2 days ago - Position Overview We are seeking an experienced Sr. embedded firmware engineer with a strong background in Rust to help re‑design and port existing... ...update protocols and architecture. Experience with medical device compliance and documentation as per FDA and ISO13485...Senior
$82.3k - $220k
...solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide. Our... ...and testing results to management. Provide training related to devices to employees, sub‑contractors, and customers. Conduct independent...SeniorFull timeFor subcontractorLocal area- ...solution validation phases through product go-live. The Project Engineer (PE) must have well rounded knowledge in all areas of medical... ...applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements...SeniorFull timeLocal areaRemote workFlexible hours
FUJIFILM Corporation
Boston, MA3 days ago $82.3k - $220k
## Sr. Electromagnetic Design EngineerApplyremote type: Onsite Requiredlocations: Cambridge... ...and space exploration to biomedical engineering, lives often depend on the solutions we... ...motors, resolver, and other electro-magnetic devices for fielded, real-world applications. You...SeniorFull timeFor subcontractorLocal area- ...simulation, and computer graphics to reduce costs and improve engineering productivity across all steps of the design and manufacturing... ...assembly tools, fixtures, ergonomic aids, and error-proofing devices are represented and used in the software. Write clear product...Senior
- Overview Job Title: Engineer, Combination Device MS&T (JP13077c) Location: Cambridge, MA 02138 Business Unit: Physical Methods Development Modelling and Emerging Methods Employment Type: Contract Duration: 2+ years with likely extensions and/or conversion to hire....Contract work
$62.5k - $245k
...solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide. Our... ...across sensor development, electro‑mechanical and solid‑state device design, control systems, sensor readout electronics, mechanical...SeniorFor subcontractor
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Device Engineering Sr. Engineer. Be the first to apply!
Related searches
- senior automation controls engineer Cambridge, MA
- senior accounts payable Cambridge, MA
- senior brand designer Cambridge, MA
- senior business analyst contract Cambridge, MA
- senior app developer Cambridge, MA
- senior digital account manager Cambridge, MA
- director sr. director clinical operations Cambridge, MA
- senior specialist Cambridge, MA
- senior research manager Cambridge, MA
- senior account executive Cambridge, MA