{"id":4317633,"url":"https://alion.io/job/haemonetics-principal-design-quality-engineer","title":"Principal Design Quality Engineer","company":{"id":4471,"name":"Haemonetics","domain":"haemonetics.com","url":"https://alion.io/company/haemonetics","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":86,"open_postings":9,"ghost_share":0,"stale_share":0.556,"repost_share":0,"time_to_fill_p50_days":56,"computed_at":"2026-11-14T05:58:10Z"}},"role":"MedTech","role_family":"MedTech","seniority":"lead","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"FMEA","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-11-13T00:00:00Z","employer_posted_date":"2026-11-13","last_verified_at":"2026-11-14T16:58:39Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.\nJob Details:\nJob Summary:\nPrincipal Design Quality Engineer will provide leadership in the design and implementation of world-class quality engineering to support activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification and validation, and design control. Activities would drive prevention, detection of defects at the earliest phase of product design, continuous improvement and customer satisfaction.\nREQUIREMENTS:\nProvide Quality leadership for new product development and product change management for: Provide leadership, and technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems. Support global product registration needs by acting as the liaison for technical questions as it pertains to design control and compliance to external standards.\nProvide leadership & support to process excellence initiatives including Six-sigma, design excellence & lean thinking.\nRepresent Quality department as a cross-functional team member for product portfolios, new product development projects, and product change projects.\nManage project quality plans. Lead or participate in the translation of Voice-of-Customer into development Requirements.\nSupport the development team in the creation, review, and approval of engineering Requirements & Specifications in accordance with standard operating procedures.\nLead cross-functional teams in the development, update, and release of risk management documentation inclusive of but not limited to: Hazard Analysis, Risk Management Plan & Report, FMEA’s (Use, Design & Process), Fault Tree Analysis (FTA).\nLead or support the development team in the creation, review, and approval of engineering development plans & test plans.\nSupport the development team in the creation, review, and approval of engineering test protocols and reports in support of design verification, design validation, and process validation.\nLead the development team in creation, review, and approval of critical-to-quality specifications. Support development team in the creation, review, and approval of traceability of user requirements, engineering specifications, and verification & validation testing.\nLead measurement systems analysis for acceptability and develop, support, & approve validation protocols and reports for test methods.\nDefine statistical testing methods and sampling in support of verification and validation testing.\nAbility to support any Product Line Portfolios and actively support 1 or more Product Line Portfolios.\nEnsure accuracy and completeness of the Design History File and the Device Master Record.\nCompile, review, and analyze failure data to provide feedback to the development team.\nMentor, develop, coach, and / or supervise less experienced quality engineers.\nSUPPORT QUALITY SYSTEM BY:\nProvide leadership & support to process excellence initiatives including Six-sigma, design excellence & lean thinking.\nEnsuring compliance to and enforcement of all required elements from regulations, standards, policies, standard operating procedures, and instructions.\nSupporting and administering quality system elements including but not limited to: Design Controls, CAPA, Non-Conformance, Complaint, Deviation, Document Controls, Labeling, etc..\nLead continuous improvement projects and reviews of policies, procedures, instructions, and training. Ensure the ongoing readiness for and participate in any potential internal/external audits and inspections.\nQUALIFICATIONS:\nBS in Engineering in Electrical, Biomedical, Mechanical, other equivalent technical engineering discipline required (Advanced degree, Masters or PhD, substitute 2 years experience below) \n8 years in a medical device or equivalent regulated environment.\n8 years Design Quality Engineering or equivalent design experience required Professional certification as one or more of the following:\n Certified Quality Engineer, Certified Reliability Engineer, Certified Six Sigma Black Belt\nPay Transparency:\nThe pay range for this role is:\n$103,600.00-$176,400.00/Annual\nThe base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job-knowledge, skills, and experience in prior relevant roles.\nIncentives may also be provided as part of Haemonetics’ employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role.\nIn addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks’ vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits.\nDepending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email .\nApplicants must be legally authorized to work in the United States. Haemonetics will not provide employment visa sponsorship for this position, either now or in the future.\nEEO Policy Statement","description_format":"text","description_chars":6163,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Flexible time off","Parental leave"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Blood & Tissue Banks"],"lifecycle":[{"event":"open","at":"2026-11-14T16:58:39Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 3 · green card filings: 1","filings_12m":3,"filings_prev_12m":1,"green_card_filings_12m":1,"median_offered_wage_usd":137500,"route":null,"cap_exempt":false,"checked_at":"2026-11-14T07:33:33+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":0}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":1,"expected_fill_days":56,"reasons":["conf:3","win:early"],"computed_at":"2026-11-14T20:33:14Z"},"pay":null,"html_url":"https://alion.io/job/haemonetics-principal-design-quality-engineer","json_url":"https://alion.io/job/haemonetics-principal-design-quality-engineer.json","meta":{"generated_at":"2026-11-14T20:33:14Z","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":25884,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-15T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":4471},"rest":"https://alion.io/mcp/rest/get_company?id=4471"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhaemonetics-principal-design-quality-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Fhaemonetics-principal-design-quality-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fhaemonetics-principal-design-quality-engineer"},{"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/haemonetics-principal-design-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhaemonetics-principal-design-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4317633}},{"tool":"search_jobs","arguments":{"company":"haemonetics.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4317633},"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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