Sr. Engineer - Combination Product Inhalation Device Lead

Amgen Inc

Senior engineer position leading systems engineering and device development for dry powder inhaler combination products at Amgen. The role involves design controls, requirements engineering, supplier oversight, and cross-functional collaboration to deliver integrated drug-device-capsule solutions.

Responsibilities

Lead systems engineering and device development for DPI combination product programs
Own Design History File and Design and Development Plan deliverables for DPI device constituent
Establish and maintain traceability from user needs through design outputs and verification evidence
Develop and execute design verification strategies including supplier evidence assessment and bridging needs
Coordinate with regulatory, manufacturing, clinical, and cross-functional teams on technical decisions and lifecycle support

Requirements

Doctorate degree, or Master's with 2+ years engineering experience, or Bachelor's with 4+ years engineering experience
Direct experience developing dry powder inhaler platforms and combination products
Expertise in design controls, requirements engineering, and Design History File activities
Knowledge of inhalation fundamentals including device resistance, airflow, and aerosolization
Experience with supplier technical assessment and design verification strategies
Strong cross-functional collaboration and regulatory/quality integration skills

Apply

Vacancy posted 5 days ago

Similar jobs that could be interesting for youBased on the Sr. Engineer - Combination Product Inhalation Device Lead in Cambridge, MA vacancy

Senior Engineer/Manager, Device Development — Combination Products
...Role: Senior Engineer/Manager, Device Development - Combination Products leading technical execution and program management for autoinjectors, prefilled syringes, or wearable injectors within biopharma drug development pipelines. Responsibilities overseeing device...
Senior
Jobleads-US
Boston, MA
5 days ago
Senior Engineer/Manager, Device Development — Combination Products
$146k - $161k
...class antibodies that were engineered by Paragon Therapeutics... ...Senior Engineer/Manager, Device Development — Combination Products Location: Hybrid, Waltham... ...Overview: We are seeking a Sr. Engineer/Manager, Device... ...the day‑to‑day technical lead for one or more assigned...
Senior
Contract work
Jobleads-US
Boston, MA
2 days ago
Senior Device Development Lead, Combination Products
...Scorpion Therapeutics is seeking a Senior Engineer/Manager for Device Development focused on combination products (autoinjectors, prefilled syringes, or wearable injectors). You will lead technical execution and program management, ensuring robust design controls and regulatory...
Senior
Jobleads-US
Boston, MA
5 days ago
Senior Device Development Lead, Combination Products
...Inc. in Waltham, MA is seeking a Senior Engineer/Manager, Device Development to lead hands-on technical development for combination product programs (autoinjector, prefilled syringe... ...asset pipeline. Reporting to the Director/Sr. Director, you will drive design controls...
Senior
Jobleads-US
Boston, MA
1 day ago
Chief Quality Leader, Device & Combination Products
Biogen is seeking the Head of Quality for Device and Combination Products to lead the global quality strategy, overseeing the Device quality organization... ..., and continuous improvement, partnering with engineering, supply chain, and external CRO/CMO teams in a fast-paced...
Suggested
Biogen, Inc.
Cambridge, MA
2 days ago
Senior Device Development Lead, Combination Products
...Oruka Therapeutics in Waltham, MA is seeking a Senior Engineer/Manager, Device Development — Combination Products to lead hands-on device engineering and program leadership for autoinjector and prefilled-syringe programs within the drug asset pipeline. Reporting to...
Senior
Jobleads-US
Waltham, MA
2 days ago
Senior Engineer II, Device Development
$117k - $157k
...qualified candidate for the role of Senior Engineer II in the Device Development group.The Senior... ...innovative drug delivery devices and combination products. This role will support both new product... ...verification and validation plans.Lead technical issues to resolution by...
Senior
Full time
Contract work
Temporary work
Local area
Biogen Idec
Somerville, MA
3 days ago
Senior Product Development Engineer -Mechanical Engineering (Hybrid Boston) (IVD and ed Dev Exp preferred)
$78.4k - $133.4k
...Summary: We are seeking a Senior Product Development Engineer with strong mechanical design experience to lead the design and development of disposable device components for an in-vitro diagnostic... .... The ideal candidate will combine strong mechanical design fundamentals...
Senior
Hourly pay
Full time
Contract work
Temporary work
Monday to Friday
Flexible hours
Haemonetics
Boston, MA
3 days ago
Senior Lead, Product Marketing - Accessories & Apparel
$130k - $170k
...daily lives.WHOOP is hiring a Senior Lead of Apparel & Accessories Product Marketing to drive the development... ...in partnership with design, engineering, and development teamsIntroduce and... ...we view total compensation as the combination of base salary, equity, and benefits...
Senior
Full time
WHOOP
Boston, MA
18 hours ago
Sr. GaN Device Engineer
Job Title: Sr. GaN Device EngineerLocation: Somerville, MA - will provide relocation assistance!Compensation: $150K - $250K DOERequirement... ...design Position OverviewWe are seeking a skilled GaN Device Engineer to join our innovative team. The ideal candidate will be responsible...
Senior
Relocation package
CyberCoders
Somerville, MA
3 days ago
Senior Product Safety and Compliance Engineer- Medical Devices
$92.2k - $141.4k
About Us SharkNinja is a global product design and technology company, with... ...Product Safety & Compliance Engineer - Medical DevicesNPD Compliance - Medical Devices & Consumer ProductsThe Senior Product... ...senior, high-ownership role: you will lead multiple certification projects...
Senior
Temporary work
Local area
Flexible hours
Shift work
SharkNinja
Needham, MA
1 day ago
Senior Engineer (Product)
$125k - $205k
...unforgettable campaigns. By combining real creator relationships, trusted... ..., and revenue. Trusted by leading enterprise brands including... ...com.About the role:The Senior Engineer is responsible for driving... ...innovate—directly influencing product velocity and engineering culture...
Senior
Permanent employment
Local area
Remote work
Later
Boston, MA
18 hours ago
Senior Device Quality Engineering Lead (Cambridge, MA)
$138k - $185k
...recruiter directly. About This Role: As the Senior Device Quality Engineering Lead, you will hold a pivotal role in ensuring the quality... ...of design control and risk management activities for combination products and medical devices. This senior-level position...
Senior
Full time
Temporary work
Local area
Biogen
Cambridge, MA
4 days ago
Principal Product Security Engineer - Medical Device
...Medtronic's Cardiac Ablation Solutions division seeks a Principal Product Security Engineer to lead cybersecurity initiatives for medical devices and embedded systems. The role focuses on integrating security controls, conducting vulnerability assessments, and driving...
Medtronic
Newton, MA
5 days ago
Device Engineering Sr. Engineer
...Amgen seeks a senior mechanical engineer to support drug delivery device development within their Design for Robustness framework. The role involves executing... ...with manufacturing, quality, and suppliers to improve product robustness and reduce variation-driven failures...
Senior
Amgen
Cambridge, MA
a month ago
Senior Medical Device Manufacturing Quality Engineer
...seeking a Senior Manufacturing Quality Engineer to support scale-up of regulated manufacturing... ..., and Operations to enable reliable production. Reporting to the Director of Quality... ...workflows suitable for Class II/III medical devices, with hands-on #J-18808-Ljbffr Axoft
Senior
Axoft
Cambridge, MA
3 days ago
Senior Manufacturing Engineer Medical Device
...Senior Manufacturing Engineer Medical Device About the job Senior Manufacturing Engineer Medical... ...sterilization, and packaging. Create production-level drawings and optimize designs... ...equipment guides, and process validations. Lead or contribute to pFMEA and implement...
Senior
Contract work
Work at office
Right Hire Consulting LLC
Cambridge, MA
1 day ago
Sr. Product Development Engineer
...Author and maintain design control documentation for combination drug-device and biologic products, including Design History Files (DHF). Ensure compliance... ...design outputs, including support of Human Factors Engineering activities. Develop and support design outputs,...
Senior
Katalyst Healthcares & Life Sciences
Boston, MA
4 days ago
Senior Quality Engineer - Lead Root Cause & Compliance
...Draper in Cambridge, MA is seeking a Quality Engineer (DMTS) to ensure products meet the highest quality standards and to investigate issues across the lifecycle from design to test. The role requires leading cross-functional teams, applying Lean Six Sigma, and implementing...
Senior
Jobleads-US
Cambridge, MA
1 day ago
Sr Manager R&D Mechanical Engineering
...Senior Manager leading a global mechanical engineering team developing next-generation orthopedic robotic systems... ...s Joints robotics group. The role combines people leadership with hands-on... ...regulatory compliance for medical device products. Responsibilities Lead,...
Senior
Johnson & Johnson
Boston, MA
4 days ago
Sr. Site Reliability Engineer I
$134.25k - $214.8k
...justice issues with our ecosystem of devices and cloud software. Like our products, we work better together. We... ...ImpactAs a Senior Site Reliability Engineer within the APX SRE organization,... ..., geographic market, and often a combination of all these factors. Our benefits...
Senior
Work experience placement
Work at office
Remote work
Flexible hours
Axon
Boston, MA
3 days ago
Sr. Product Engineer (Systems Assembly)
$62.5k - $237.5k
...solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide. Our... ...about Draper, visit Job Description Summary Draper is seeking a Product Manufacturing Engineers who can bridge the gap between advanced...
Senior
Full time
Local area
The Charles Stark Draper Laboratory, Inc.
Cambridge, MA
2 days ago
Senior Product Safety Engineer, Renewable Energy
$100k - $125k
...trusted service across the electrical and electronics industry. Combining the teams, capabilities, and shared commitment to safety... ...Job Description Position Summary The Senior Product Safety Engineer, Renewable Energy is an experienced, plug-and-play impact player...
Senior
Full time
Monday to Friday
Eurofins USA Consumer Product Testing
Boston, MA
3 days ago
Senior Engineer: Mathematical Modeling and Simulation
$115.49k - $156.26k
...transforming your career.Senior Engineer Mathematical Modeling and... ...s change the world. Amgen's Combination Product Operations Digital and Data... ...numerical models of drug delivery devices (in-silico modeling assets)... ...Simulation will not only lead and collaborate heavily with...
Senior
Full time
Flexible hours
Amgen
Somerville, MA
18 hours ago
Principal Production Test Engineer
$95k - $245k
...defense and space exploration to biomedical engineering, lives often depend on the solutions we... ..., visit .Job Description Summary:The Production Test Engineering & Execution Group at... ...in CCA, E/M assemblies, or MEMS devices.Applicants selected for this position will...
Full time
Local area
Draper Laboratory
Somerville, MA
3 days ago
Mechanical Engineering Senior
...Senior Mechanical Engineer (Boston, MA, United States)About the OpportunityJoin an innovative... ...a Senior Mechanical Engineer to drive product architecture, design, integration,... ...DFA methodologies. Background in medical devices, aerospace, automotive, industrial automation...
Senior
Real Staffing Group
Boston, MA
3 days ago
Senior Human Factors Engineer
$129.37k - $175.03k
...you are responsible for leading HFE/UE planning,... ...of Amgen drug delivery devices using HFE/UE best practices... ...the medical device, combination product and bio-pharmaceutical... ...Human Factors / Usability Engineer is a thought leader... ...Responsibilities:The Sr. HFE/UE responsibilities...
Senior
Full time
Local area
Flexible hours
Amgen
Cambridge, MA
4 days ago
Sr. ABAP BTP Engineer
$130.8k - $209.4k
...highly skilled Senior SAP BTP Engineer to design, develop, and... ...delivery, enhancements, and production support by contributing to solution... ...environment such as Pharma or Medical Device is preferred.Pay & BenefitsAt... ...we have aspired to build the leading mRNA technology platform, the...
Senior
Permanent employment
Full time
Work at office
Work from home
Moderna Therapeutics
Cambridge, MA
4 days ago
Quality Engineering Senior
$150k - $195k
...WHOOP is seeking a Senior NPI Quality Engineer, (Hardware) to lead Product Quality for a portfolio of hardware... ...electronics, wearables, medical devices, or similarly complex hardware.Experience... ...we view total compensation as the combination of base salary, equity, and...
Senior
Full time
Contract work
Work at office
Relocation
WHOOP
Boston, MA
1 day ago
Senior Technology Product Manager - GTM Enablement and Launch Lead
$85.6k - $149.4k
About the RoleAs a Senior Technology Product Manager - GTM Enablement and Launch Lead, you will play a critical role in... ...at the intersection of Product, Engineering, Product Marketing, Sales,... ...and aligned.The ideal candidate combines strong program execution skills with...
Senior
Full time
Work at office
Wolters Kluwer
Waltham, MA
18 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Sr. Engineer - Combination Product Inhalation Device Lead. Be the first to apply!