Senior Hardware Engineer - Medical Devices
Quick facts
- Type
- Full-time
- Location
- Tarrytown, NY
- Experience
- 10–15 years
- Skills
- Medical
- Industry
- Engineering — 214 open jobs
- Visa in listing
- H-1B
- Apply
- Free to apply — never pay anyone for a job offer or visa sponsorship
Job description
Job Description
Job Title: Senior Hardware Engineer - Medical Devices
Location: Tarrytown, NY, USA
Positions: 1
Experience: 10-15 Years
Work Authorization: USC, Green Card, H-1B
Work Arrangement: To be confirmed
Job Summary
We are seeking an experienced Senior Hardware Engineer with 10-15 years of hands-on experience in medical device hardware development, electronics design, and product engineering. The ideal candidate will have strong expertise in analog, digital, and mixed-signal circuit design, PCB development, embedded hardware interfaces, power electronics, and hardware verification and validation.
The candidate will be responsible for leading hardware design and development activities for regulated medical devices, ensuring product safety, reliability, performance, and compliance with applicable medical device standards. Experience with medical equipment, in-vitro diagnostic (IVD) systems, risk management, and regulatory compliance is highly desirable.
Key Responsibilities
- Lead hardware design, development, testing, and sustaining engineering activities for regulated medical devices.
- Design and review analog, digital, and mixed-signal electronic circuits.
- Perform schematic design, component selection, PCB design reviews, and hardware architecture evaluations.
- Develop hardware interfaces for microcontrollers (MCUs), FPGAs, sensors, and other electronic components.
- Design and support battery-powered systems, power electronics, power management circuits, and DC-DC converters.
- Implement and evaluate high-speed communication interfaces, including USB, Ethernet, SPI, I2C, CAN, and RS232.
- Apply signal integrity (SI), power integrity (PI), design for manufacturing (DFM), and design for testability (DFT) principles.
- Execute hardware verification and validation (V&V), troubleshooting, failure analysis, and performance testing.
- Conduct hardware risk assessments and support risk management activities in accordance with ISO 14971.
- Support compliance testing and product development activities related to IEC 60601-1, IEC 60601-1-2, and ISO 13485.
- Maintain hardware design documentation, engineering change records, and product lifecycle information using Windchill or Agile PLM.
- Support manufacturing transfers, supplier changes, component obsolescence management, and cost optimization initiatives.
- Collaborate with Systems Engineering, Firmware, Mechanical Engineering, Quality, Regulatory, and Manufacturing teams.
- Provide technical guidance during design reviews, product troubleshooting, and continuous improvement initiatives.
Required Qualifications and Skills
- 10-15 years of experience in hardware development, preferably focused on medical devices or regulated medical equipment.
- Strong hands-on experience in analog, digital, and mixed-signal circuit design.
- Experience with PCB design, schematic capture, PCB layout reviews, and component selection.
- Knowledge of signal integrity, power integrity, and high-speed PCB design constraints.
- Experience with microcontrollers, FPGAs, sensor interfaces, and embedded hardware integration.
- Strong understanding of power electronics, battery-powered devices, and DC-DC converters.
- Experience with communication interfaces such as USB, I2C, SPI, RS232, Ethernet, CAN, GSM, and Bluetooth.
- Experience with hardware verification, validation, testing, and troubleshooting.
- Hands-on experience with hardware risk management and failure analysis.
- Familiarity with medical device standards, including IEC 60601-1, IEC 60601-1-2, ISO 14971, and ISO 13485.
- Proficiency with PCB design tools such as Altium Designer and/or OrCAD.
- Experience with product lifecycle management (PLM) tools such as Windchill or Agile PLM.
- Strong analytical, problem-solving, documentation, and cross-functional collaboration skills.
Preferred Qualifications
- Prior experience designing medical equipment, diagnostic instruments, or in-vitro diagnostic (IVD) systems.
- Experience with motion control systems, motor drivers, and precision sensors.
- Experience supporting regulatory submissions, EMC testing, manufacturing transfers, and product sustaining activities.
- Experience with design for manufacturing, design for testability, and hardware cost optimization.
Ideal Candidate Profile
The ideal candidate is a hands-on senior hardware engineer with a strong background in medical device electronics, PCB design, embedded hardware interfaces, and regulated product development. The candidate should be capable of independently driving hardware engineering activities from design through verification, validation, compliance, and manufacturing support.
Visa sponsorship record: Envision LLC
Sponsors occasionally| Fiscal year | H-1B LCAs | USCIS approvals | USCIS denials | PERM |
|---|---|---|---|---|
| FY2026 | 6 | — | — | — |
| FY2025 | 1 | 1 | 0 | 1 |
| FY2024 | — | 0 | 1 | — |
This exact kind of role (Electrical Engineers) isn't among the roles Envision LLC sponsored most often.
Roles they sponsor most
- business analyst2 LCAs · median $109k
- software engineer2 LCAs · median $132k
- civil project engineer1 LCA · median $100k
- data engineer1 LCA · median $109k
- research program manager1 LCA · median $81k
Which visas can work for this job
Occupation: Electrical Engineers (SOC 17-2071) — estimated from the job title.
- Mentioned in the listing
H-1B
- H-1B cap-exempt employer
Regular cap-subject employer — a new H-1B needs to win the lottery in March (unless you already hold cap-counted H-1B status).
- TN (citizens of Canada and Mexico)
This kind of role may fit the USMCA profession “Engineer” — it depends on the actual duties. No lottery, no cap; you need the matching degree or license.
- E-3 (Australia) and H-1B1 (Chile, Singapore)
Same degree requirement as H-1B, but no lottery and a separate quota that is rarely filled.
- O-1 (extraordinary ability)
For candidates with awards, publications, press, a high salary or critical roles at distinguished organizations. No cap, no lottery; the employer files a petition.
- STEM OPT extension (F-1 students)
Requires an E-Verify employer. We didn't find this company in the E-Verify list — ask HR.
- Green card (EB-2 / EB-3 via PERM)
Filed 1 PERM labor certification: they have a track record of sponsoring permanent residence.
Salary vs prevailing wage
Electrical Engineers · New York-Newark-Jersey City, NY-NJ. Annual prevailing wages set by the Department of Labor (OFLC).
| Level | Prevailing wage | H-1B lottery odds* |
|---|---|---|
| Level I | $88,358 | ~15% |
| Level II | $108,930 | ~31% |
| Level III | $129,522 | ~46% |
| Level IV | $150,093 | ~61% |
The listing has no salary, so we can't place it on a wage level. Ask the employer which wage level they'd file at: Level III–IV registrations get 3–4 entries in the H-1B lottery.
* Odds are DHS projections for the FY2027 wage-weighted lottery (actual results vary by year and employer). Since the FY2027 cap season the H-1B lottery is weighted by wage level: Level I = 1 entry, II = 2, III = 3, IV = 4. The level is set by the offered wage against the prevailing wage for the occupation and worksite. Separately, a $100,000 fee for new H-1B petitions for workers outside the US was announced in 2025; as of September 2026 a federal court ruling keeps it unenforceable while appeals continue — check the current status.
Sources: U.S. Department of Labor OFLC disclosure data (H-1B/H-1B1/E-3 LCA, PERM), OFLC prevailing wage data, USCIS H-1B Employer Data Hub, E-Verify participating employers. Data loaded: LCA FY2024–FY2026, PERM, USCIS Data Hub, OFLC wages; updated 2026-10-03. Employers are matched by name, so records of companies with similar names can occasionally be mixed up. This is general information, not legal advice — talk to an immigration attorney about your case.