For the Senior Device Engineer position we are seeking a motivated and technically curious engineer to join our Combination Product Development team. In this role, you will support the development and lifecycle management of prefilled syringes (PFS), auto-injectors (AI), on-body injectors, and other combination products for biologic therapies. This is an excellent opportunity for an engineer with experience in medical device, pharmaceutical, or combination product development who is looking to expand their expertise in design controls (21 CFR 820, ISO 13485), design verification, and product performance evaluation. In this role, you will independently lead technical activities, contribute to cross-functional development programs, support regulatory and quality objectives, and collaborate with senior engineers and subject matter experts to advance innovative drug-device combination products in a regulated environment. How You'll Spend Your Day Product Development Support - Lead or independently contribute to design control activities, including user needs, design inputs, design outputs, risk management documentation, verification planning, traceability, and DHF content for combination product development programs. - Support technical evaluations of device components and assembly configurations (e.g., stoppers, barrels, needle shields, springs, plungers). - Apply systems engineering principles to define and manage system and subsystem support requirements, interfaces, critical performance attributes, and verification evidence across development, interface definition, traceability, and integration of device, drug, user, and manufacturing considerations throughout combination product development. - Contribute to component and system-level testing of drug delivery devices to evaluate injection time, glide force, and dose accuracy. - Develop and execute comprehensive test strategies, including statistically sound test matrices, designed to evaluate product performance, robustness, design margins, and the impact of critical design and process variables throughout the product lifecycle. - Support lifecycle management activities for commercial and late-stage combination products, including technical assessments for change controls, deviations, CAPAs, complaints, supplier changes, and product performance trends. Test Method Development - Assist in the development and qualification of physical test methods (e.g., for syringe functionality, BLE/glide force, injection time). - Perform hands-on testing using force testers (e.g., Instron, Zwick), timers, and mechanical fixtures in the lab. Documentation & Reporting - Document experimental work in technical reports, protocols, and lab notebooks with attention to Good Documentation Practices (GDP). - Contribute to design verification protocols and reports under the supervision of senior engineers. Investigations & Technical Support - Participate in root cause investigations of product performance deviations (e.g., high BLE force, long injection time). - Analyze and summarize test data using statistical tools under guidance (e.g., JMP, Excel, or Minitab). Cross-Functional Collaboration - Collaborate with Regulatory Affairs, Quality, Manufacturing, Analytical Development, Human Factors, Clinical, and other cross-functional partners to ensure user needs, usability risks, essential performance requirements, and submission expectations are appropriately translated into development and verification strategies. - Collaborate with external development partners, component suppliers, contract manufacturers, and test laboratories to ensure technical activities are clearly defined, executed, documented, and aligned with regulatory and quality expectations. Your Skills and Experience - BS with 4-6 years, or MS with 2-4 years, of relevant pharmaceutical, biotech, medical device, or combination product development experience. - Foundational understanding of mechanical systems and materials, preferably with experience supporting prefilled syringes, autoinjectors, needle safety devices, on-body injectors, wearable injectors, or other parenteral delivery systems. - Hands-on lab experience with mechanical testing, instrumentation, or materials evaluation. - Strong attention to detail and ability to follow procedures and document results clearly. - Good communication skills and willingness to learn in a regulated environment. - Exceptional organizational and time-management skills, with the ability to independently manage multiple complex tasks and shifting priorities in a dynamic environment. How We'll Take Care of You We offer a competitive benefits package, including: - Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. - Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. - Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays. - Life and Disability Protection: Company paid Life and Disability insurance. - Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. Make sure to apply through our internal career site on Twist-your one-stop shop for career development