Career CategoryProcess Development
Job DescriptionSenior Device Assembly EngineerWhat you will doThe Senior Device Engineer is responsible for providing technical leadership for the commercial ConfiPen device assembly platforms throughout the product lifecycle. This role leads engineering activities supporting device assembly equipment design, lifecycle management, manufacturing support, continuous improvement, and global commercialization of drug-device combination products.
The position is responsible for the technical development and sustainment of ConfiPen devices and their final drug product assemblies, and packaging equipment, ensuring products and assembly processes continue to meet safety, quality, performance, reliability, and regulatory requirements. The engineer serves as a technical subject matter expert, partnering across Device Engineering, equipment system owners, Combination Products Organization, Manufacturing, Quality, Regulatory, Supply Chain, and external suppliers to support product improvements, troubleshooting, manufacturing investigations, design changes, and commercial launches.
This position also leads engineering laboratory activities supporting device assembly development, Design of Experiments (DOE), manufacturing investigations, and process optimization utilizing advanced assembly monitoring technologies.
Key ResponsibilitiesProduct Development & Lifecycle Management- Lead design change implementation and lifecycle management activities for commercial ConfiPen devices.
- Implement final drug product requirements, engineering specifications, and technical solutions for drug-device combination products.
- Ensure compliance with Design Control requirements throughout the product lifecycle.
- Support development of engineering strategies that ensure products meet safety, efficacy, functionality, and regulatory requirements.
Technical Leadership- Lead cross-functional engineering teams supporting product development and commercialization activities as it relates to device assembly.
- Serve as the technical subject matter expert for device design, assembly processes, testing, and lifecycle management.
- Provide technical leadership to the manufacturing site and external development partners.
- Mentor junior engineers and provide technical guidance across multiple engineering disciplines.
- Manage project scope, schedules, budgets, technical risks, and engineering deliverables.
Engineering Laboratory & Process Development- Lead engineering investigations and process development activities within a laboratory environment to evaluate device assembly processes, materials, components, and manufacturing equipment.
- Design, execute, and analyze Design of Experiments (DOE) to characterize assembly processes, optimize critical process parameters, and establish robust operating windows.
- Develop laboratory test methods, fixtures, and engineering studies to support product development, lifecycle management, manufacturing investigations, and continuous improvement initiatives.
- Lead technical investigations by defining experimental strategies, developing hypotheses, selecting appropriate statistical methodologies, and translating results into actionable engineering recommendations.
- Partner with Process Development, Manufacturing, Quality, and external equipment suppliers to transition laboratory learnings into commercial manufacturing processes.
Verification, Validation & Testing- Lead device assembly product testing to demonstrate product safety, performance, reliability, and efficacy.
- Develop verification strategies and author engineering protocols, reports, and technical documentation.
- Create and execute verification protocols, test methods, and engineering studies.
- Analyze engineering data using statistical methods to support design acceptance, process capability, and product performance.
- Support design verification, design validation, and engineering characterization activities.
Manufacturing Support- Support technology transfer activities to AOH manufacturing lines.
- Provide engineering support during manufacturing scale-up and commercial product launches.
- Lead troubleshooting of automated assembly and testing equipment.
- Utilize manufacturing data and in-process monitoring systems to identify trends, investigate process deviations, and drive continuous improvement.
- Collaborate with manufacturing teams to improve equipment reliability, process capability, and operational efficiency.
Assembly Process Monitoring & Process Optimization- Lead technical investigations involving automated assembly equipment, force-displacement (force/travel) monitoring systems, and process capability to ensure robust manufacturing performance and product quality.
- Analyze force-displacement (force/travel) signatures and process monitoring data to understand assembly behavior, identify failure mechanisms, and optimize assembly parameters.
- Develop, optimize, and validate assembly process windows utilizing statistical methodologies and engineering experimentation.
- Support qualification and optimization of automated assembly processes, including force-controlled assembly, press-fit operations, and functional testing.
- Collaborate with equipment suppliers and manufacturing engineers to implement process improvements and corrective actions.
Quality & Regulatory Compliance- Own engineering change records, deviations, CAPAs, and quality records.
- Lead root cause investigations involving quality events, manufacturing issues, and device failures.
- Support Failure Mode and Effects Analysis (DFMEA/PFMEA) and product risk management activities.
- Provide technical leadership and authorship for regulatory submissions and technical reports.
- Ensure compliance with applicable Design Controls, Quality Systems, and global medical device regulations.
Supplier & External Partner Management- Collaborate with suppliers regarding component specifications, manufacturing capability, and quality requirements.
- Support supplier qualification and component investigations.
- Interface with Process Development and external partners as the technical subject matter expert.
Essential Skills & Experience- Understanding of global Medical Device Design Control regulations (21 CFR 820.30) and associated Design Control processes.
- Strong understanding of Design Planning, Design Inputs, Design Reviews, Design Verification, Design Validation, Design Transfer, and Design History Files.
- Demonstrated experience designing, executing, and analyzing Design of Experiments (DOE) to support product development, process optimization, and root cause investigations.
- Experience developing laboratory-based engineering studies to evaluate device assembly processes, equipment, and component interactions.
- Experience supporting and troubleshooting automated mechanical assembly processes and manufacturing equipment.
- Experience interpreting and utilizing force-displacement (force/travel) signatures to evaluate assembly performance, detect abnormal conditions, and support engineering investigations.
- Knowledge of manufacturing process monitoring systems, process capability analysis, and statistical evaluation of assembly process performance.
- Strong understanding of statistical methods including DOE, regression analysis, capability analysis, Statistical Process Control (SPC), and measurement system evaluation.
- Experience leading root cause investigations utilizing structured problem-solving methodologies.
- Experience supporting Design Failure Mode and Effects Analysis (DFMEA) and product risk management activities.
- Proficiency in interpreting engineering drawings and using CAD software such as SolidWorks.
- Knowledge of ASTM, ISO, and applicable engineering standards.
- Demonstrated ability to lead cross-functional teams including Engineering, Manufacturing, Quality, Regulatory, Supply Chain, Marketing, and external suppliers.
- Strong project management, communication, technical writing, and organizational skills.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The packaging professional we seek will possess these qualifications.
Basic QualificationsDoctorate degree
OR
Master's degree and 2 years of Engineering and/or Operations experience
OR
Bachelor's degree and 4 years of Engineering and/or Operations experience
OR
Associate's degree and 8 years of Engineering and/or Operations experience
OR
High school diploma / GED and 8 years of Engineering and/or Operations experience
Preferred Qualifications- Bachelor's degree in mechanical engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline.
- 7+ years of engineering experience supporting medical devices, drug-device combination products, or other regulated products.
- 5+ years supporting manufacturing or commercial operations.
- 3+ years of experience in medical device, pharmaceutical, or combination product development.
- Experience supporting drug delivery systems such as, pen injectors, wearable injectors, syringes, or related delivery platforms.
- Experience supporting engineering laboratories with device assembly development, manufacturing investigations, and process optimization.
- Experience with force/displacement monitoring systems or equivalent in-process assembly monitoring technologies.
- Experience developing assembly process windows using laboratory experimentation and statistical methodologies.
- Experience with automated assembly equipment including servo-controlled presses, force-displacement monitoring systems, vision inspection, and functional testing equipment.
- Experience analyzing force-displacement data to establish process capability, investigate failures, and improve manufacturing robustness.
- Experience with Design for Manufacturability (DFM), Design for Assembly (DFA), tolerance analysis, and mechanical assemblies.
- Experience supporting IQ/OQ/PQ and manufacturing process validation.
- Proficiency with Minitab, JMP, or equivalent statistical software.
- Proficiency with SolidWorks, CAD, engineering drawings, and assemblies.
- Strong understanding of:
- 21 CFR Part 820 / Quality System Regulation
- ISO 13485
- ISO 14971
- EU Medical Device Regulation (2017/745)
- Combination Product regulations (21 CFR Part 4)
- Demonstrated ability to provide technical leadership, influence cross-functional teams without direct authority, mentor junior engineers, and drive engineering decisions across complex development and commercial programs.
- Strong interpersonal, communication, and technical writing skills with the ability to coordinate engineering activities across multiple global sites.
What you can expect of usAs 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, including remote and hybrid work arrangements, where possible
Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.
careers.amgen.comSponsorshipSponsorship for this role is not guaranteed.
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