Information Technology Jobs in Pinehurst Massachusetts

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At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today’s mission and stay ahead of tomorrow’s threat. Our team solves tough, meaningful problems that create a safer, more secure world. 

The Systems Engineering & Test Capabilities team discipline is seeking a Test Architect to support the NASAMS® surface to air defense system programs.  The Test Architect (TA) will be accountable for architecting a technically sound approach for the Test and Evaluation (T&E) strategy for the entire lifecycle of the product along with influencing the prime item architecture to support that strategy.
 

What You Will Do

• Responsible for test strategy for all aspects of the program and defines metrics to gauge progress.

• Responsible for defining or optimizing test environments and requirements to ensure on-time deliveries.

• Responsible for interface and coordination with internal and external organizations on test strategy, coordination, execution, and reporting activities.

• Extensive interaction with Program Managers, Directorate Leads, Chief Engineers, and technical subject matter experts (SMEs).

• Coordinate with other program disciplines to draw on their SMEs to address emergent issues across the systems, software, and hardware domains.

• Represent the interests of the Systems Integration and Test (SI&T) discipline on the program.

• Interface with the customer community on a regular basis to share test status, issues, and address programmatic concerns.

• Knowledge base for Model Based Systems Engineering and how to use this in Integration and Test for test strategy.

• International travel up to 20%, Regular travel between Raytheon locations in Massachusetts and Southern New Hampshire is required.

Qualifications You Must Have

• Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and a minimum of 10 years of prior relevant experience

• Experience with formal system test activities, including ground tests, flight tests, system verification, and system integration check out events

• Ability to obtain Interim Secret U.S. government issued security clearance is required prior to start date with the ability to obtain a Final Secret U.S. government issued security clearance after start.

Qualifications We Prefer

• Excellent technical writing and formal presentation experience

• Strong proven communication skills

• Raytheon Test Architect Certification

• Experience with Department of War or similar major programs throughout the product lifecycle

• Active and transferable U.S. government issued security clearance is required prior to start date.

What We Offer

• Our values drive our actions, behaviors, and performance with a vision for a safer, more connected world. At RTX we value: Safety, Trust, Respect, Accountability, Collaboration, and Innovation.

• Relocation

Learn More & Apply Now!

• Please consider the following role type definition as you apply for this role.

• Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products.

• Welcome to Raytheon in Andover, MA

As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote.

RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act.

Privacy Policy and Terms:

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Job Title : Medical Assistant/Technician (Hospital Corpsman) Category / Component : Enlisted • Both Overview Hospital Corpsmen assist healthcare professionals and provide medical and dental care to Sailors, Marines, and their families across clinics, hospitals, ships, and field units, gaining broad clinical, technical, and operational experience.

Key Responsibilities Perform emergency medical treatment for Sailors, Marines, and specialized units such as SEALs and Seabees; provide basic and emergency dental care and process dental X rays; serve as operating room technician and assist in surgery; administer preventive care and medications including immunizations and IVs; conduct physical exams and assist in diagnosing and treating diseases and injuries; maintain patient records, perform clinical tests, and support physicians and nurses in a wide range of specialties.

What to Expect Hands on patient care with shift work and possible on call duties; field training and deployments with Marine and expeditionary units and embarked medical departments on ships; continuous certification and recertification in areas such as basic life support, trauma care, and tactical combat casualty care; mix of clinic, ward, and field environments with rapid response in emergent situations and a strong emphasis on teamwork and readiness.

Work Environment Assignments in Navy hospitals and clinics, aboard aircraft carriers and other ships, with Marine units in garrison and field environments, and occasionally on submarines; work in exam rooms, wards, operating rooms, emergency departments, aid stations, and field medical sites; close integration with medical teams, line units, and joint or coalition partners.

Pathways, Training & Advancement Recruit Training followed by Hospital Corpsman A School at Fort Sam Houston, Texas; numerous advanced C schools that lead to Navy Enlisted Classifications in areas such as Independent Duty Corpsman, Fleet Marine Force, preventive medicine, surgical technology, respiratory therapy, pharmacy, radiology, laboratory, dental, and dive medicine; progressive professional development through leadership courses and warfare qualifications such as Fleet Marine Force and Surface, Aviation, or Expeditionary pins where applicable.

Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for qualified Sailors from other ratings who meet screening and performance criteria; Reserve accession for prior service Hospital Corpsmen and select civilian medical professionals when manning needs allow.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: United States citizenship or equivalent status as allowed by policy; high school diploma or equivalent; at least 17 years of age; interest in healthcare and willingness to work in clinical and field environments, potentially under stressful conditions; ability to meet medical, vision, and physical fitness standards required for medical and operational assignments.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.

Job Title : Medical Assistant/Technician (Hospital Corpsman) Category / Component : Enlisted • Both Overview Hospital Corpsmen assist healthcare professionals and provide medical and dental care to Sailors, Marines, and their families across clinics, hospitals, ships, and field units, gaining broad clinical, technical, and operational experience.

Key Responsibilities Perform emergency medical treatment for Sailors, Marines, and specialized units such as SEALs and Seabees; provide basic and emergency dental care and process dental X rays; serve as operating room technician and assist in surgery; administer preventive care and medications including immunizations and IVs; conduct physical exams and assist in diagnosing and treating diseases and injuries; maintain patient records, perform clinical tests, and support physicians and nurses in a wide range of specialties.

What to Expect Hands on patient care with shift work and possible on call duties; field training and deployments with Marine and expeditionary units and embarked medical departments on ships; continuous certification and recertification in areas such as basic life support, trauma care, and tactical combat casualty care; mix of clinic, ward, and field environments with rapid response in emergent situations and a strong emphasis on teamwork and readiness.

Work Environment Assignments in Navy hospitals and clinics, aboard aircraft carriers and other ships, with Marine units in garrison and field environments, and occasionally on submarines; work in exam rooms, wards, operating rooms, emergency departments, aid stations, and field medical sites; close integration with medical teams, line units, and joint or coalition partners.

Pathways, Training & Advancement Recruit Training followed by Hospital Corpsman A School at Fort Sam Houston, Texas; numerous advanced C schools that lead to Navy Enlisted Classifications in areas such as Independent Duty Corpsman, Fleet Marine Force, preventive medicine, surgical technology, respiratory therapy, pharmacy, radiology, laboratory, dental, and dive medicine; progressive professional development through leadership courses and warfare qualifications such as Fleet Marine Force and Surface, Aviation, or Expeditionary pins where applicable.

Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for qualified Sailors from other ratings who meet screening and performance criteria; Reserve accession for prior service Hospital Corpsmen and select civilian medical professionals when manning needs allow.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: United States citizenship or equivalent status as allowed by policy; high school diploma or equivalent; at least 17 years of age; interest in healthcare and willingness to work in clinical and field environments, potentially under stressful conditions; ability to meet medical, vision, and physical fitness standards required for medical and operational assignments.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.

Job Title : Medical Assistant/Technician (Hospital Corpsman) Category / Component : Enlisted • Both Overview Hospital Corpsmen assist healthcare professionals and provide medical and dental care to Sailors, Marines, and their families across clinics, hospitals, ships, and field units, gaining broad clinical, technical, and operational experience.

Key Responsibilities Perform emergency medical treatment for Sailors, Marines, and specialized units such as SEALs and Seabees; provide basic and emergency dental care and process dental X rays; serve as operating room technician and assist in surgery; administer preventive care and medications including immunizations and IVs; conduct physical exams and assist in diagnosing and treating diseases and injuries; maintain patient records, perform clinical tests, and support physicians and nurses in a wide range of specialties.

What to Expect Hands on patient care with shift work and possible on call duties; field training and deployments with Marine and expeditionary units and embarked medical departments on ships; continuous certification and recertification in areas such as basic life support, trauma care, and tactical combat casualty care; mix of clinic, ward, and field environments with rapid response in emergent situations and a strong emphasis on teamwork and readiness.

Work Environment Assignments in Navy hospitals and clinics, aboard aircraft carriers and other ships, with Marine units in garrison and field environments, and occasionally on submarines; work in exam rooms, wards, operating rooms, emergency departments, aid stations, and field medical sites; close integration with medical teams, line units, and joint or coalition partners.

Pathways, Training & Advancement Recruit Training followed by Hospital Corpsman A School at Fort Sam Houston, Texas; numerous advanced C schools that lead to Navy Enlisted Classifications in areas such as Independent Duty Corpsman, Fleet Marine Force, preventive medicine, surgical technology, respiratory therapy, pharmacy, radiology, laboratory, dental, and dive medicine; progressive professional development through leadership courses and warfare qualifications such as Fleet Marine Force and Surface, Aviation, or Expeditionary pins where applicable.

Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for qualified Sailors from other ratings who meet screening and performance criteria; Reserve accession for prior service Hospital Corpsmen and select civilian medical professionals when manning needs allow.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: United States citizenship or equivalent status as allowed by policy; high school diploma or equivalent; at least 17 years of age; interest in healthcare and willingness to work in clinical and field environments, potentially under stressful conditions; ability to meet medical, vision, and physical fitness standards required for medical and operational assignments.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.

As an Assistant Branch Manager at Rockland Trust, you play a pivotal role in supporting the Branch Manager in overseeing daily operations, driving business growth, and ensuring exceptional customer service. Each day, you create a positive and motivating team environment to help staff meet branch goals and objectives, and cultivate a customer-centric retail environment focused on identifying and providing team-based solutions for customer financial needs.

With a consultative, team-oriented sales personality and outstanding personal customer skills, you take responsibility for ensuring that every customer receives a consistent World Class Customer Experience with every branch staff interaction whether in person, over the phone, or through digital channels. You are a leader in the branch, personally executing a high level of customer service and modeling these behaviors to the staff.

What You’ll Do:

• Work in direct collaboration with the Branch Manager to:
• Train, motivate, develop, and coach employees.
• Accept responsibility for individual and overall branch sales, and customer experience performance.
• Nourish branch enthusiasm for participating in product promotion and other areas of opportunity.
• Track and report branch performance.
• Maintain the operational integrity of the branch.
• Ensure proper controls are maintained over all branch operational processes and regulatory requirements.
• Communicate new and/or changed policies and procedures to branch staff.
• Develop and implement sales programs and maintain a positive sales and service environment.
• Develop and maintain effective lobby management and customer outreach efforts.
• Maintain and utilize Salesforce platform.
• Manage referral targets on both an individual basis as well as for the branch team, leveraging a needs-based, consultative sales approach and online produce recommendation guides.
• Proactively identify, report, and resolve customer issues to ensure a positive customer experience.
• Ensure team compliance with RTC policies and procedures by leading by example, demonstrating our RTC core values and delivery on our customer promises.
• Maintain a thorough knowledge of all products and services provided by the bank including Consumer Products, Home Lending, Business and Cash Management alternatives; act as a resource to others in product knowledge.
• Actively demonstrate technology and self-service channels with new and existing customers promoting ATM, online banking, and mobile banking alternatives.
• Understand and utilize Regional Based Staffing and branch staffing models to coordinate in-branch customer demand while facilitating and supervising proactive outreach such as outbound calling and external sales calls.
• Consistently meet or exceed sales and service expectations by effectively leveraging RTC needs-based product recommendations; consistently meet or exceed requirements on mystery shops.
• Show initiative in maintaining a solid foundation of product knowledge by taking advantage of trainings as they are offered and completing required trainings within the timeframes provided.
• Represent Rockland Trust by establishing meaningful roots in the communities it serves.
• Supervise branch staff in the absence of the Branch Manager.
• Assume responsibility for additional reporting duties and responsibilities as required.

What You’ll Experience:

• Meaningful relationships: We believe that Each Relationship Matters, and are fully committed to creating a respectful and inclusive environment where everyone is given the chance to succeed.
• Commitment to community: We believe supporting our communities is essential, and are committed to helping those in need.
• Recognition & reward: We believe all colleagues should be recognized for their contributions
• Training & development: We believe all colleagues are critical to our future, and we will invest in their success by providing educational experiences and resources to manage and navigate their careers.
• Comprehensive benefits: Our goal is to offer our colleagues a generous benefits package, and an environment that supports a healthy work-life balance. Our benefits include competitive compensation with performance incentive awards, Health Insurance, Dental Insurance, Vision, Pet Insurance, 401K retirement plan, Long Term Disability & Life Insurance, Child Care Reimbursement, Tuition Assistance for graduate and undergraduate programs, an award winning wellness program and much more.

Required Qualifications:

• Must be or become a Notary Public and NMLS certified.
• Ability to generate sales excitement and act as a coach and mentor to the staff.
• Proficient in Microsoft Word and Excel with ability to operate a variety of office equipment.
• Excellent verbal and written communication skills.
• Consultative, team-oriented sales personality with outstanding customer service skills.
• Sound risk decision-making skills and strong operational proficiency.
• Supervisory abilities to provide constructive and positive feedback, and manage performance.
• Ability to meet compliance and audit requirements.
• High degree of professionalism and ability to demonstrate tact and diplomacy when needed.
• Ability to work within normal office requirements, with long periods of standing and continuous customer support.
• Willingness and ability to work within a flexible work week, which may include weekends, as customer needs dictate.
• Serves as the bank representative in community activities
• Ability to successfully complete our training program

Preferred Skills/Experience:

• College degree and two to four years of retail banking or equivalent experience preferred.
• The ideal candidate should possess Retail Banking experience in a sales environment with strong supervisory experience.

Who We Are:

At Rockland Trust, we believe that being a great place to bank starts with being a great place to work. When our colleagues are valued and cared for, they’re empowered to make a difference for our customers and communities.

As one of The Boston Globe’s “Top Places to Work” for the past fourteen years, we know that finding the right people is just the beginning. Through competitive benefits, enriching development opportunities, and a respectful and collaborative culture, we’ve built a workplace that enhances our colleagues’ lifestyle and inspires them to reach their full potential.

For over 116 years, we have been dedicated to strengthening the neighborhoods we live in and serve. Rockland Trust offers a wide range of banking, investment, and insurance services to help individuals and businesses work toward their financial goals with more than 120 branches located throughout Massachusetts, as well as commercial banking, investment management offices, and residential lending centers across Massachusetts and Rhode Island.

Rockland Trust is the Bank Where Each Relationship Matters®. In pursuit of that promise, we foster a respectful and inclusive work environment where everyone is given the chance and resources to succeed.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, disability status, protected veteran status, or any other characteristic protected by law. Additionally, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Now that you’ve heard a little bit about us, we’d love to hear more about you. Submit your application and come help us strengthen our communities- one relationship a time.

UII America, Inc., a subsidiary company of Shanghai United Imaging Intelligence Healthcare Co. Ltd. (UII), is building an organization of highly-motivated, talented and skillful AI experts and software developers to strengthen our R&D power and address the need of our innovative products in the USA market. United Imaging Intelligence (UII) is committed to providing AI solutions for medical devices, imaging, and diagnosis – to helping clients better understand and embrace AI. United Imaging Intelligence is led by two world-renown leaders in the AI industry. Together, they will lead UII in focusing on “empowerment” and “win-win.” UII empowers doctors and equipment in order for doctors and hospitals to win, for research institutions to win, and for third-party companies to win. UII America, Inc. is building a world-class research and development team in Boston, MA.

We are seeking Research Interns to contribute to our R&D efforts in Artificial Intelligence, Medical Imaging, and Computer Vision. As a part of our team, you will collaborate with senior experts, tackle challenging technical problems, and gain valuable experience developing AI solutions for healthcare. Exceptional work during the internship may lead to contributions to practical product solutions or publications in top-tier journals and conferences.

Responsibilities:

• Conduct cutting-edge research on AI and Deep Learning algorithms to address challenges in medical imaging.
• Explore and develop medical image foundation models, multi-modality models, and generative AI techniques.
• Collaborate with senior team members to implement and refine advanced algorithms for medical imaging analysis and computer vision.
• Translate research findings into practical applications for real-world healthcare challenges.
• Contribute to team-oriented projects in a collaborative and innovative research environment.
• Stay updated on emerging trends and technologies in AI and medical imaging to drive impactful advancements.

Qualifications:

• Currently pursuing an MS or PhD in Computer Science, Electrical Engineering, Biomedical Engineering, Statistics, Applied Mathematics, or a related field.
• A proven track record of publications in relevant fields (e.g., Machine Learning, AI, Computer Vision, Medical Imaging) is a plus.
• Knowledge of state-of-the-art AI methods including deep learning, generative AI, foundation models and multi-modality models.
• Familiarity with medical imaging analysis or computer vision.
• Proficiency in Python and C/C++.
• Hands-on experience with deep learning frameworks such as PyTorch or TensorFlow.
• Strong problem-solving abilities, critical thinking, and self-motivation.
• Effective communication skills and a collaborative mindset.

As a Director of AI-enabled Quality Systems, you will own the day-to-day execution and continuous improvement of SiPhox’s Quality Management System (QMS), supporting the development, validation, and production of regulated products from early prototypes through clinical and manufacturing stages. This is a hands-on, high-impact role in a fast-moving, multidisciplinary environment where quality must keep pace with innovation.

You will work closely with engineering, operations, and clinical teams to ensure that products, processes, and documentation meet internal requirements and applicable regulatory standards. Your focus will be on practical quality execution, ensuring verification and validation (V&V), design controls, and production systems are implemented effectively, issues are resolved efficiently, and results can be trusted.

In this role, you will serve as both a quality gatekeeper and a collaborative partner, helping teams build compliant processes without slowing progress. You will also play a key role in strengthening and scaling the QMS as the company grows, identifying opportunities to improve efficiency, clarity, and robustness across development and operations.

This role will have a high impact on SiPhox’s success, with significant potential for career development and growth as the company progresses through FDA submissions, manufacturing ramp up, and product launch.

Responsibilities

Quality System Leadership

• Serve as a senior owner and architect of the ISO 13485 Quality Management System (QMS), ensuring scalability, inspection readiness, and alignment with FDA (21 CFR 820 / QMSR), EU IVDR (if applicable), and other global requirements.
• Lead strategic evolution of document and record control processes, ensuring robust change control, traceability, and configuration management across design and manufacturing.
• Drive quality system maturity, ensuring processes are right-sized for a high-growth, fast-paced medical device environment.

Design Controls & Product Development

• Lead and oversee design control activities in accordance with 21 CFR 820.30 and ISO 13485, ensuring clear traceability from user needs through verification, validation, and risk management.
• Partner with engineering, assay development, software, and operations teams to embed quality into product development from concept through commercialization.
• Ensure Design History Files (DHFs), Device Master Records (DMRs), and technical documentation are complete, audit-ready, and submission-ready.

Regulatory Submission Support

• Lead quality strategy and documentation support for FDA submissions (510(k), De Novo, etc.), including substantial involvement in at least one cleared IVD submission.
• Ensure verification & validation documentation, risk files, and QMS elements meet regulatory expectations.
• Support responses to FDA questions, deficiency letters, and inspection observations.

CAPA & Continuous Improvement

• Own and elevate the CAPA system, ensuring robust investigations, root cause analysis (e.g., 5-Why, Fishbone, FMEA), and effective corrective actions.
• Analyze quality data trends to identify systemic risks and drive proactive improvement.
• Mentor cross-functional teams in structured problem-solving methodologies.

Risk Management

• Lead risk management activities in accordance with ISO 14971.
• Ensure risk controls are appropriately linked to design inputs, verification/validation, production controls, and post-market activities.
• Drive integration of risk management throughout the product lifecycle.

Audit & Inspection Readiness

• Lead internal audit programs and supplier quality audits.
• Serve as a primary quality representative during ISO 13485 audits and FDA inspections.
• Drive timely and effective responses to audit findings and regulatory observations.

Post-Market & Compliance

• Oversee complaint handling, adverse event reporting (e.g., MDR), and post-market surveillance processes.
• Ensure effective feedback loops between post-market data and design/process improvements.

Training & Culture

• Architect and maintain a scalable, role-based training system with measurable effectiveness.
• Promote a strong culture of quality, ownership, and compliance across the organization.

Required Qualifications

• 8+ years of experience in medical device quality within an ISO 13485 environment.
• 5+ years of experience in IVD development and/or manufacturing.
• Direct participation in one or more successful FDA 510(k) submissions for an IVD device.
• Deep working knowledge of:
• ISO 13485
• 21 CFR 820 (and QMSR transition awareness)
• ISO 14971
• Design controls for IVD systems (including assay and/or instrument development)
• Demonstrated experience leading CAPA investigations and cross-functional quality initiatives.
• Experience serving as a key quality representative during external audits or inspections.
• Bachelor’s degree in engineering, life sciences, or related field (advanced degree preferred).
• Authorized to work in the U.S. without sponsorship.

Highly Desirable Experience

• Experience with combination systems (instrument + consumable IVD).
• Experience in CLIA-regulated laboratory environments.
• Experience with software quality (IEC 62304 familiarity).
• Experience building or significantly scaling a QMS in a startup environment.
• Experience supporting international submissions (CE marking under IVDR).

Additional notes

SiPhox Health is creating an entirely new category of at-home technology that brings advanced biological measurement into everyday life. Our platform brings together silicon photonics, microfluidics, motion systems, sensing, thermal control, and embedded computing inside a compact device that performs complex biochemical analysis in minutes. We are building a consumer product that has never existed before. It integrates optics, chemistry, mechanics, biology and electronics into a seamless experience designed for millions of homes.

We offer competitive benefits, including a Life Time Fitness membership and the opportunity to work in a fast-paced, mission-driven environment building the future of home health.