{"id":3249621,"url":"https://alion.io/job/caldera-medical-rd-systems-engineer","title":"R&D Systems Engineer","company":{"id":4423053,"name":"Caldera Medical","domain":"calderamedical.com","url":"https://alion.io/company/calderamedical","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"JobScore","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":95000,"max_usd":181000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":713},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"FDA 510(k)","optional":false},{"name":"Verification & Validation","optional":false},{"name":"FMEA","optional":true}],"status":"live","first_seen_at":"2026-10-15T18:15:34Z","employer_posted_date":"2026-10-15","last_verified_at":"2026-11-01T03:19:50Z","board_verified":true,"closed_at":null,"days_open":16,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":16},"description":"R&D Systems Engineer\nResearch & Development\nCaldera Medical’s Mission - To Improve the Quality of Life for Women!\nAbout Caldera Medical\nCaldera Medical is committed to improving the quality of life for women worldwide through innovative pelvic health and neuromodulation solutions. Our growing R&D team is developing the next generation of connected device technology while continuing to advance the surgical products clinicians rely on today.\nHeadquartered in Westlake Village, CA, with international operations in Neuchâtel, Switzerland, Caldera combines clinical insight with engineering excellence to bring meaningful therapies to market.\nThe Opportunity\nDo you see the whole system - and love being the person who makes mechanical, electrical, and software work come together? We're looking for a Systems Engineer to be the technical thread across our R&D programs.\nWhen a mechanical change affects a board, or a software decision changes a test plan, you'll be the one who connects the dots, aligns the team, and keeps the design documentation solid. It's an individual contributor role with real influence: you'll help multiple programs reach launch and shape how our products come to market.\nWhat You'll Do\nConnect mechanical, electrical, and software work across multiple active programs, keeping design decisions aligned and documented.\nAuthor and maintain requirements, design inputs, and design outputs with traceability through FDA 510(k) submission.\nApply board- and component-level understanding to how electrical and mechanical pieces fit together.\nPartner with Electrical, Mechanical, and firmware/software teams to move programs through design freeze and launch.\nEnsure the accuracy and thoroughness of verification and validation (V&V) plans across disciplines.\nSupport design FMEAs and risk management with Quality.\nPrioritize across a varied project portfolio, focusing effort where it matters most.\nRequired Experience\nBSEE, BSECE, or equivalent.\n5-7 years of systems engineering experience in medical devices; an electrical engineering background is a plus.\nA track record of aligning mechanical, electrical, and software engineers without direct authority.\nExperience authoring requirements, design inputs/outputs, and traceable documentation supporting FDA 510(k) submissions.\nWorking knowledge of V&V planning and execution, design FMEA, and risk management.\nComfort managing several programs at different stages at once.\nDon't meet every requirement? If you bring strong medical device systems experience and most of the above, we encourage you to apply.\nWhy This Role Matters\nAs our pipeline grows, R&D needs one person keeping every discipline working from the same requirements. You'll have a hand in every program you touch - and see the products you helped shape reach the women who need them.\nCompetitive Compensation, Comprehensive Benefits, and more!\nRelocation assistance available for this role\nMedical and Dental Benefits\nVision Coverage\n401(k) with 4% matching contributions after 90 days of employment\nBasic Life and AD&D\nUnlimited Vacation Policy\n6 Weeks Paid Maternity Leave\n10 paid holidays - including your birthday!\nBeing surrounded by amazing people!\n(This role is being filled directly by our in-house recruiting team. We are not working with outside agencies for this position.)\nOur Culture - Where Career and Passion come together!\nA culture of family and team… not a corporate goliath where you're just another number.\nAll employees get a seat at the table and have influence with management. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California.\nThe Women's Health Initiative is the heart of what we do; every day we put underprivileged women first.\nOur goal is to treat 1 million women suffering from incontinence by 2027!\nWho is Caldera Medical?\nCaldera Medical is dedicated to improving the quality of life for women through innovative surgical solutions for stress urinary incontinence, pelvic organ prolapse, polyps, and fibroids.\nOur products are trusted by surgeons worldwide, and our commitment extends beyond medical advancements. We foster strong partnerships with surgeons and lead the largest humanitarian program in women’s health, aiming to provide treatment to one million underserved women by 2027.\nGuided by integrity, we prioritize patients, customers, employees, and the community over profit. As the fastest-growing women’s health company, we remain committed to expanding education and access to life-changing care for women everywhere.\nCaldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.","description_format":"text","description_chars":4949,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Relocation assistance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":true,"industries":["Health Care","Women’s Health & Maternity"],"lifecycle":[{"event":"open","at":"2026-10-25T20:24:49Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":16,"expected_fill_days":81,"reasons":["conf:2","win:early"],"computed_at":"2026-11-01T06:10:25Z"},"pay":null,"html_url":"https://alion.io/job/caldera-medical-rd-systems-engineer","json_url":"https://alion.io/job/caldera-medical-rd-systems-engineer.json","meta":{"generated_at":"2026-11-01T06:19:58Z","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":9833,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"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":4423053},"rest":"https://alion.io/mcp/rest/get_company?id=4423053"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcaldera-medical-rd-systems-engineer"},{"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%2Fcaldera-medical-rd-systems-engineer"},{"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%2Fcaldera-medical-rd-systems-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/caldera-medical-rd-systems-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcaldera-medical-rd-systems-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3249621}},{"tool":"search_jobs","arguments":{"company":"calderamedical.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3249621},"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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