Biogen
Senior Engineer II, Device Development
Cambridge, MA, USA · Senior
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odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
$2,933 more — $119,933 — moves this role to Level III and 3 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $119,933 would place this position at wage Level III. That figure is within the posted range, and I'd like to target it. This role classifies under "Industrial Engineers" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Industrial Engineers (17-2112) · Boston-Cambridge-Newton, MA-NH. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- Biogen is seeking a qualified candidate for the role of Senior Engineer II in the Device Development group.
- This is a hybrid role based at our Headquarters in Cambridge, MA.
Responsibilities
- Develop and maintain combination product Design History File content, including design input requirements, design outputs, design reviews, verification and validation strategies, protocols, reports, and traceability documentation.
- Support risk management by translating knowledge of user interactions, clinical use scenarios, device design, and product performance into risk assessments
- establishing traceability to design input requirements
- Lead technical issues to resolution by documenting investigations, performing root cause analysis, evaluating vendor complaints, assessing design and process changes, and communicating conclusions and recommendations to cross-functional stakeholders.
- Support design changes and lifecycle management activities, including impact assessments, technical investigations, risk analyses, change control documentation, and reverification or revalidation planning.
- Support Device Master Record content and related technical documentation for combination products, including assembly, labeling, packaging, test methods, specifications, and supplier-controlled device constituent part documentation.
- Control device constituent part development by establishing design outputs, documenting control strategy, assessing observations and deviations, evaluating root cause, and leading technical issues with suppliers and internal partners through resolution.
- Support innovation projects by conducting technology and drug delivery system landscaping, evaluating feasibility, developing concepts or prototypes where applicable, and translating learnings into recommendations for pipeline programs.
- Oversee verification activities at contract laboratories by developing experimental plans, analyzing test data, preparing technical reports, and troubleshooting technical and design problems in drug delivery systems.
- Contribute to regulatory filings and responses to regulatory questions by preparing device and combination product content, supporting technical justifications, and liaising with third parties, including contract design and manufacturing companies, testing laboratories, and subject matter experts.
Requirements
- You are a driven, high-performing engineer with hands-on device or combination product development experience, strong technical judgment, and effective interpersonal and communication skills.
- You are comfortable working across functions, partnering with external organizations, and applying structured problem-solving to advance programs through development and lifecycle management.
- Minimum Required Qualifications:
- Bachelor's degree in biomedical, electrical, mechanical, or related engineering discipline with at least 6 years of experience in device and/or combination product development, including 3+ years of experience with drug delivery and combination products such as autoinjectors, pre-filled syringes, wearable injectors, pen injectors, or drug reconstitution devices.
- Experience working within medical device and combination product standards and regulations, including ISO 13485, ISO 14971, 21 CFR Part 4, 510(k), PMA, MDD, MDR, and other applicable US and EU regulatory expectations.
- Experience supporting new product introduction, including design, engineering analysis such as first-principles modeling and FEA, prototyping, development, and testing of extruded, molded, and/or assembled device products, as well as relevant testing and modeling methodologies.
Nice to have
- Advanced degree in biomedical, electrical, mechanical, or related engineering discipline.
- Experience with a requirements, risk management, tracebility software tool (e.g. JAMA DOORS, Polarion, CodeBeamer).
- Job Level: Management
- Additional Information
- The base compensation range for this role is: $117,000.00-$157,000.00
- including, but not limited to:
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- Medical, Dental, Vision, & Life insurances
- Paid Maternity and Parental Leave benefit
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Employee stock purchase plan
- Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Company info
- We are a global team with a commitment to excellence, and a pioneering spirit.
- As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.