{"id":522295,"url":"https://alion.io/job/integra-lifesciences-sr-principal-engineer-product-development","title":"Sr Principal Engineer, Product Development","company":{"id":35496,"name":"Integra LifeSciences","domain":"integralife.com","url":"https://alion.io/company/integra-lifesciences","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":85,"open_postings":17,"ghost_share":0,"stale_share":0.588,"repost_share":0,"time_to_fill_p50_days":51,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Backend","role_family":"Backend","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Mansfield, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":166750,"max":228850,"currency":"USD","period":"year","gross":null,"usd_annual":228850},"salary_estimate":null,"experience_years_min":15,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"GD&T","optional":false},{"name":"ISO 10993","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Python","optional":false},{"name":"SolidWorks","optional":false},{"name":"Verification & Validation","optional":false},{"name":"Design of Experiments","optional":true},{"name":"FDA 510(k)","optional":true}],"status":"live","first_seen_at":"2026-08-25T00:00:00Z","employer_posted_date":"2026-08-25","last_verified_at":"2026-11-04T02:23:13Z","board_verified":true,"closed_at":null,"days_open":71,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":71},"description":"Changing lives. Building Careers.\nJoining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.\nPosition Summary\nWe are seeking a highly accomplished Senior Principal Engineer to serve as a senior technical leader and individual contributor in the development of advanced medical devices featuring complex electromechanical and electro-fluidic systems. This role focuses on neurosurgical, critical care, and fluid-management technologies, with deep expertise spanning sensor integration, signal processing, embedded systems, polymer device design and manufacturing, biocompatibility, and rigorous application of design controls.\nThe ideal candidate will drive projects from early feasibility through design verification, validation, regulatory submission, and manufacturing transfer while mentoring junior engineers and serving as a key technical resource for cross-functional teams. This position requires exceptional hands-on technical depth combined with strong communication skills to translate complex engineering concepts into clear, actionable insights.\nLocation: Hybrid; candidates able to work from Mansfield, MA or Princeton, NJ.\nKey Responsibilities\nLead the design and execution of comprehensive experimental programs within a medical device Quality Management System, guiding projects from initial investigation and feasibility through formal design verification and validation (V&V) in full compliance with FDA 21 CFR Part 820 design controls and ISO 13485.\nPlan, coordinate, and execute biocompatibility evaluation programs per the ISO 10993 series in close collaboration with toxicologists, analytical chemists, and regulatory partners; interpret results, support risk management files, and contribute to regulatory submissions.\nArchitect, design, prototype, and validate analog-to-digital data acquisition systems for medical device development and automated testing, including detailed error propagation analysis, ADC characterization, analog and digital filtering, and advanced signal-processing techniques.\nDevelop and maintain Python-based data processing platforms to prototype signal-processing algorithms, efficiently ingest and analyze large heterogeneous datasets from mixed file types, perform statistical analysis, and generate clear visualizations that drive technical decision-making.\nApply Design for Manufacturability (DFM) principles to polymeric medical device components and assemblies, with expertise in design for injection molding, additive manufacturing (3D printing), precision machining of medical-grade polymers, and selection/validation of appropriate medical-grade adhesives.\nCreate and maintain high-fidelity 3D solid models and fully dimensioned 2D engineering drawings incorporating Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5 to ensure designs are robust, manufacturable, inspectable, and functionally sound.\nApply deep knowledge of bio-fluid dynamics at mesofluidic and microfluidic scales to inform device architecture, performance optimization, and testing strategies for fluid-handling medical devices.\nEffectively synthesize, condense, and communicate complex technical data, experimental results, trade-off analyses, and risk assessments through clear presentations, design reviews, and written reports for cross-functional audiences including R&D, Quality, Regulatory, Manufacturing, and senior leadership.\nProvide technical mentorship and guidance to junior engineers and technicians; contribute to the establishment of design standards, best practices, and continuous improvement within the R&D organization.\nSupport Design History File (DHF) development, risk management activities (ISO 14971), change control, and interactions with regulatory bodies or notified bodies as needed.\nRequired Qualifications\nBachelor’s degree or equivalent with 15+ years of experience; Master’s degree with 12+ years of experience; Ph.D. with 10+ years of experience in Mechanical Engineering, Systems Engineering, Electrical Engineering, or a closely related technical discipline.\nMinimum of 10 years of progressive hands-on experience in medical device product development under FDA Quality System Regulation (21 CFR Part 820) and ISO 13485, with a demonstrated track record of successfully advancing complex electromechanical or electro-fluidic devices from concept through verification, validation, and commercialization.\nProven expertise in the design, implementation, and troubleshooting of analog-to-digital data acquisition systems, including error analysis, signal conditioning, filtering, and processing for sensor-based medical devices.\nStrong proficiency in Python for scientific computing and data analysis; demonstrated ability to prototype signal-processing algorithms, process large multi-format datasets, and produce clear visualizations.\nHands-on experience developing and deploying embedded systems and automated test equipment using microcontrollers, with working knowledge of communication protocols such as RS-485, CAN-Bus, and Bluetooth.\nSolid background in Design for Manufacturability (DFM) for medical-grade polymeric devices, including injection molding, additive manufacturing, CNC machining, material selection, and adhesive bonding strategies suitable for fluid-contact or long-term use applications.\nExpert-level proficiency in 3D CAD modeling (SolidWorks preferred) and creation of 2D engineering drawings with proper GD&T application.\nStrong working knowledge of bio-fluid mechanics, particularly at mesofluidic and microfluidic scales, with ability to apply principles to device design and testing.\nExcellent verbal and written communication skills with proven ability to distill highly technical engineering information into clear, concise, and actionable content for diverse stakeholders.\nPreferred Qualifications\nHands-on experience with Computational Fluid Dynamics (CFD) simulations and Finite Element Analysis (FEA), especially for failure analysis or performance prediction of polymeric materials.\nPractical experience with MEMS sensor technologies, with strong preference for piezoresistive pressure sensing; familiarity with microfabrication processes from wafer-level processing through die attach and wire bonding.\nSolid foundation in inorganic and organic chemistry as applied to medical device materials, surface interactions, degradation mechanisms, and leachables/extractables considerations.\nExperience supporting or leading elements of regulatory submissions (e.g., 510(k), De Novo, PMA) and participating in FDA or notified body audits.\nFormal training in statistical methods, Design of Experiments (DOE), or Six Sigma (Green Belt or Black Belt).\nSalary Pay Range:\n$166,750.00 - $228,850.00 USD SalaryOur salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process.\nAdditional Description for Pay Transparency:\nSubject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).\nSubject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences\nIntegra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.\nThis site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:\nEEO Is the Law | EOE including Disability/Protected Veterans\nIntegra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at .\nUnsolicited Agency Submission\nIntegra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.\nIntegra - Employer Branding from Integra LifeSciences on Vimeo","description_format":"text","description_chars":9763,"description_truncated":false,"requirements":{"experience_years_min":15,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Equity","Life insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Regenerative Medicine","Wound Care"],"lifecycle":[{"event":"open","at":"2026-09-08T02:41:04Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 8 · green card filings: 1","filings_12m":8,"filings_prev_12m":4,"green_card_filings_12m":1,"median_offered_wage_usd":125833,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":1}],"liveness":{"score":22,"band":"cold","label":"Long shot","p_open":1,"p_active":0.503,"p_room":0.44,"age_days":71,"expected_fill_days":51,"reasons":["conf:4","stale_co","win:tail","crowd:brand"],"computed_at":"2026-11-04T06:34:25Z"},"pay":{"stated_usd_annual":228850,"is_top_pay":true},"html_url":"https://alion.io/job/integra-lifesciences-sr-principal-engineer-product-development","json_url":"https://alion.io/job/integra-lifesciences-sr-principal-engineer-product-development.json","meta":{"generated_at":"2026-11-04T12:58:45Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":19593,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":35496},"rest":"https://alion.io/mcp/rest/get_company?id=35496"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fintegra-lifesciences-sr-principal-engineer-product-development"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fintegra-lifesciences-sr-principal-engineer-product-development"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fintegra-lifesciences-sr-principal-engineer-product-development"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/integra-lifesciences-sr-principal-engineer-product-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fintegra-lifesciences-sr-principal-engineer-product-development"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":522295}},{"tool":"search_jobs","arguments":{"company":"integralife.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":522295},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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