Engineering Jobs in Somerville

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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 Air Defense Ground Equipment (ADGE) Department leads mechanical design, development, and integration of platform systems. This includes shelter systems, hardware integration, cable & interconnections, as well as facility development, and site integration. The department is comprised of individuals with technical expertise and experience in hardware design, integration, and production support. 

The ADGE department is looking for a full-time Sr. Principal Mechanical Engineer to support Patriot Missile Change Control Board (CCB) for major components and sub-assemblies, including obsolescence upgrades, procurement and supplier support

What You Will Do

• Responsibilities (Core & Day to Day) Support design specification development through production qualification reviews and release including ensuring design is manufacturable
• Participate in design peer reviews and conduct trade studies to promote sound technical decisions.
• Provide responses to supplier questions related to general design expectations and interpretation of the relevant specifications​.
• Provide guidance on Raytheon expectations for design rigor, level of TDP & MDP documentation required, typical analysis approach, and other similar topics.
• Connect suppliers with Raytheon subject matter experts as required.
• Collaborate with other engineering disciplines, non-technical disciplines, and suppliers to develop robust design solutions and resolve technical challenges.
• Work with limited supervision and meet technical, schedule, and monetary commitments.
• Apply knowledge and experience in technical problem solving and hardware development in an engaged team environment.
• Drawing generation, drawing release, and drawing change incorporation

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 unless prohibited by local laws/regulation. Or An Advanced Degree in a related field and minimum 7 years experience
• Experience with ERB/CCB process; CCB chair certification or ability to be certified.
• Experience with solid modeling, creating and documenting mechanical designs in Pro/Engineer/CREO or similar modeling tools.
• Experience working within small electromechanical or gyroscope similar assembly/products.
• Experience with Geometric Dimensioning and Tolerancing (GD&T) and ASME drawing and documentation standards and procedures

Qualifications We Prefer

• Experience with materials, load bearing structures, shock/vibration/load analysis
• Experience using Computer Aided Design (CAD) tools
• Missile portfolio including reviewing trade studies, identification of suitable alternate and interchangeable materials, or design changes as needed
• Ensure technical integrity and engineering execution across the IPTs and other functions to meet cost, schedule, and technical requirements

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 Eligibility

Learn More & Apply Now!

• 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.

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:

Click on this link to read the Policy and Terms

Date Posted:

Country:

Location:

Position Role Type:

U.S. Citizen, U.S. Person, or Immigration Status Requirements:

Security Clearance Type:

Security Clearance Status:

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. 

Are you ready to join a dynamic, comprehensive, and growing professional organization? The Systems Engineering (SE) Long Range Radars (LRR) department is seeking a Senior Systems Engineer to contribute to concept development, architectural design, requirements generation and flow-down, modeling and simulation, systems analysis, integration, testing, and evaluation of world-class Missile Defense and Sensor Systems. In this role, you will lead the technical development and sustainment of the Qatar Air Operations Defense System (AODS) platform infrastructure.

The AODS platform consists of Commercial Off-The-Shelf (COTS) servers, appliances, and networking equipment, operating in a dynamic environment with constantly evolving priorities. Every day presents a new set of challenges. Whether it’s hardware, software, networking, or a combination of all three, you’ll be challenged to learn how our systems work and identify the sources of new and unexpected issues through troubleshooting and data analysis.

We value various skills and experience, so don't hold back. Your qualifications could add tremendous value to our team. Our customers come from all different backgrounds, and so do our employees. If you're passionate about what you could accomplish here, we'd love to hear from you!

What You Will Do

In this role, you will collaborate across disciplines and partner with Scrum teams to implement solutions, gaining exposure to every aspect of the system while directly contributing to its success. Key responsibilities include:

• Leading system-level operations center sustainment, execution, and reporting.

• Troubleshooting hardware and software issues to maintain site operations and ensure system reliability.

• Developing and upgrading platform capabilities, including operating systems, networking, and cybersecurity components.

• Interfacing with and reporting to U.S. Government customers and Program Leadership on system development and operational status.

• Preparing integration and implementation documentation, such as plans, procedures, and reports.

• Providing reach-back support to teams supporting the operational system in-country.

• Analyzing data from operations center hardware, software, and simulations to identify and resolve issues.

• Utilizing data analysis results to support root cause identification and resolution.

• Collaborating across multi-disciplinary engineering functions to drive performance, improve system functionality, and resolve technical challenges.

• This position will be on site in Tewksbury, MA.

Qualifications You Must Have

• Typically requires a Bachelor’s in Science, Technology, Engineering, or Mathematics (STEM) and a minimum of 5 years of prior relevant experience.

• Experience with IT, networking, and/or system administration, including: Command and Control (C2) system hardware (e.g., servers, switches, routers), Virtual Desktop Infrastructure (VDI), Virtual Machines/Containers, SQL databases, Active Directory (Windows/Linux), and/or VMware systems.

• Experience conducting technical analysis such as data analysis, troubleshooting, and/or identifying root causes.

• Experience with virtual and hyper converged platforms.

Qualifications We Prefer

• Strong ability to clearly articulate technical concepts, both verbally and in writing.

• Proven interpersonal skills for collaboration across multidisciplinary teams.

• Adaptability to dynamic, fast-paced environments with a focus on innovative solutions.

• Experience with the Systems Engineering process, including design, development, and evaluation.

• Proven ability to develop, document, and maintain processes, methods, and tools for technical execution and sustainment.

• Experience interfacing with customers to deliver technical solutions to complex problems.

• Hands-on expertise in network configuration and troubleshooting.

• Knowledge of air defense programs and large, complex systems.

• Familiarity with command and control systems involving sensors and effectors.

• Experience with Link-16 networking and interfaces.

• Proficiency in scripting languages like Python, Ruby, or PowerShell.

• Knowledge of Microsoft Active Directory, Group Policy Objects, and identity management best practices.

• A Master's degree in Engineering, Science, Mathematics, or a related discipline is preferred.

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 Eligibility– Relocation assistance available

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.

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:

Click on this link to read the Policy and Terms

Date Posted:

Country:

Location:

Position Role Type:

U.S. Citizen, U.S. Person, or Immigration Status Requirements:

Security Clearance Type:

Security Clearance Status:

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. With over 100 years of experience, we bring renowned engineering expertise to stay ahead of tomorrow’s threats. Our team solves tough, meaningful problems that create a safer, more secure world.

Raytheon is seeking a Senior Software Engineer to join the National Advanced Surface-to-Air Missile System (NASAMS) team. NASAMS is a cutting-edge air defense system that protects critical assets and population centers from aerial threats by integrating advanced radar, command and control, and missile systems. This role is based in Tewksbury, Massachusetts, where you’ll work collaboratively to deliver high-quality software solutions that support the NASAMS system effectivity chain: Detect, Decide, Engage, and Destroy.

Leveraging Agile and DevSecOps principles, you’ll design, develop, test, and deploy software for mission-critical capabilities. As a senior member of the team, you will also mentor junior engineers, fostering a culture of technical excellence and collaboration.

What You Will Do

• Design, develop, and deliver real-time software for NASAMS, including Detect, Decide, Engage, and Destroy functionalities.

• Develop solutions for target acquisition, threat evaluation, missile firing, and other critical functions.

• Maintain and deploy complex software in an Agile/DevSecOps environment with secure, high-quality, high-frequency deliveries.

• Mentor junior engineers, promoting technical growth and collaboration.

• Participate in reviews of software components to ensure quality and alignment with program requirements.

• Contribute to testing frameworks and CI/CD practices to enable efficient software validation and delivery.

• Solve problems within defined scope and ensure seamless integration of software with NASAMS hardware and systems.

What You Will Learn

• The workings of the NASAMS system, including integration with advanced radar and C2 systems.

• How to design and maintain software for complex, real-time systems supporting mission-critical functions.

• Leadership skills to coordinate and contribute to multi-disciplinary teams.

• Best practices for software testing and deployment in a DevSecOps environment.

• How to collaborate in a fast-paced, Agile environment delivering secure, high-frequency updates.

Key Contributions to NASAMS - as part of the NASAMS program, you will contribute to the following areas:

• Detect: Develop solutions for target acquisition, integrated IFF, and tracking updates.

• Decide: Implement Single Integrated Air Picture, threat evaluation, launcher assignment, and multi-missile handling.

• Engage: Create algorithms for azimuth slew, targeting data transfer, missile firing, and mission abort.

• Destroy: Support motor ignition, inertial guidance, seeker search, target lock-on, and terminal guidance.

Qualifications You Must Have

• Typically requires a Bachelor's of Science Degree in Science, Technology, Engineering or Mathematics (STEM) and a minimum of 5 years of prior relevant experience.

• Experience in programming languages (e.g., C++, Java).

• Experience with Agile and DevSecOps methodologies and tools (e.g., CI/CD pipelines, Docker, Jenkins).

• Experience leading teams and resolving complex technical challenges.

• Ability to obtain U.S. government issued Secret security clearance is required after start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance.

Qualifications We Prefer

• Strong problem-solving and communication skills.

• Extensive experience with radar software development and/or radar concepts.

• Familiarity with missile defense programs and large, complex systems.

• Hands-on experience with tools such as the Atlassian Suite (e.g., Bitbucket, Artifactory, JIRA, Confluence), Jenkins, Eclipse, and Ansible.

• Strong knowledge of Linux Operating Systems, particularly Red Hat Enterprise Linux.

• Familiarity with CI/CD environments and pipelines, including experience with DevSecOps methodologies.

• Advanced knowledge of software integration, testing frameworks, and debugging tools.

• Ability to succeed in a fast-paced, dynamic environment with time-critical requirements.

• Proven experience contributing to a team environment and developing creative solutions.

• Demonstrated ability to promote a culture of continuous learning and collaboration.

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 Eligible.

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.

This position requires a security clearance. DCSA Consolidated Adjudication Services (DCSA CAS), an agency of the Department of Defense, handles and adjudicates the security clearance process. More information about Security Clearances can be found on the US Department of State government website here:  

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:

Click on this link to read the Policy and Terms

#2588 IT Business Partner - GMP Manufacturing Operations

Company and Role

Company is a publicly traded global pharmaceutical company with strong roots in the United States.

The IT Business Partner - GMP Manufacturing Operations will lead all technology implementation, production support, and maintenance activities within the Manufacturing Suite, ensuring systems are reliable, secure, and compliant with GMP and GxP requirements. This position will be responsible for authoring and enforcing SOPs to meet GMP guidelines, onboarding new equipment, maintaining compliance of existing systems, and driving the implementation of new IT GxP solutions such as Data Historian and LIMS.

Expectations

• Own and foster the IT-to-business relationship for Manufacturing operations, ensuring alignment of technology strategy with manufacturing leadership priorities.
• Define and manage a support and operating model for the Manufacturing Suite, maintaining application production environments to quality standards and delivering high-value implementation projects on time and on budget.
• Lead a team of internal and external, onshore and offshore IT professionals to execute implementation and support activities, ensuring SLA adherence and customer satisfaction.
• Provide oversight and expertise in Manufacturing change control, deviation management, and CAPA processes to ensure IT systems support regulatory and quality expectations; and proficient in tools like Veeva Vault, TrackWise Digital.
• Work closely with the Process Automation (PA) group to define clear roles and responsibilities between IT and PA, ensuring seamless collaboration and system ownership across both functions.
• Manage partner/vendor relationships, ensuring external service providers deliver quality and performance according to service levels and regulatory requirements.
• Develop, write, and enforce Standard Operating Procedures (SOPs) to ensure adherence to GMP guidelines across all IT-supported manufacturing processes.
• Oversee onboarding of new equipment into Manufacturing Suite, ensuring systems are validated, compliant, and maintained according to regulatory standards.
• Maintain compliance of all existing equipment and IT systems, ensuring continuous alignment with GMP and GxP requirements.
• Lead implementation of new IT GxP systems within the suite (e.g., Data Historian, MES, LIMS), ensuring proper validation, integration, and ongoing support.
• Ensure adherence to regulatory requirements (FDA, GxP), cybersecurity standards, and departmental policies, practices, and SOPs.
• Partner with global and local IT management to align best practices across Company, introducing process improvements and leveraging industry learnings.

Experience

• Bachelor’s degree in computer science, Information Systems, Engineering, or related field.
• Minimum of ten (10) years’ IT experience supporting pharmaceutical manufacturing suite or with at least 5 years in technical leadership roles.
• Proven experience managing IT vendor relationships and service providers in a regulated environment.
• Demonstrated expertise in GMP and GxP compliance, including authoring, maintaining, and enforcing SOPs for IT systems supporting manufacturing operations.
• Demonstrated experience in configuring IT components for manufacturing equipment and writing user requirements
• Strong background in equipment onboarding, validation, and lifecycle management to ensure systems remain compliant and audit-ready.

Preferred Experience

• Hands-on experience with ERP, Data Historian, Laboratory Information Management Systems (LIMS), and other GxP manufacturing support technologies.
• Hands -on experience: onboarding and installing pharmaceutical manufacturing equipment, configuring the systems for the equipment and writing the user requirements.

Benefits

• Medical, Dental, Vision benefits
• Short Term and Long Term Disability
• Generous PTO, Holiday Schedule and Company Shut Downs
• Annual Bonus Potential
• Recipient of “Best Places To Work” multiple times for a positive corporate culture.

About us

*Prior experience with Military or Aerospace Account Manager within the electronic component industry is required.

Future Electronics is a global leader in electronics distribution and has been for over 50 years. We are recognized for providing quality service, leading global supply chain solutions, the most effective custom engineering services, and the largest available-to-sell inventory.

About the Role:

We are seeking a highly motivated and technically capable Electronics Component Distribution Salesperson (SAM) to expand our presence in the Military & Aerospace (Mil/Aero) market segment. This role focuses on building strategic relationships, driving design in opportunities, and developing long-term revenue within defense and aerospace OEMs, tier 1/2 suppliers, and key engineering organizations.

If you thrive in a program-driven, compliance-focused environment and enjoy selling high-reliability electronic components and solutions, this is an excellent opportunity to grow your career

Key Responsibilities:

• Develop and execute a strategic sales plan for Mil/Aero accounts

• Identify new business opportunities across primes, subcontractors, and engineering teams

• Drive design in engagement with engineering teams and coordinate with FAEs

• Manage complex sales cycles, including quoting, negotiations, and long-term agreements (LTAs)

• Support customer requirements across NPI, prototype, production, and sustainment phases

• Maintain accurate forecasting, pipeline development, and CRM updates

• Collaborate with inside sales, supply chain, quality, and franchised suppliers

• Ensure compliance with ITAR/EAR regulations, DFARS requirements, and counterfeit mitigation standards (AS5553)

• Track competitive activity and provide feedback on market trends and customer programs

Qualifications:

• 3–7+ years of experience in electronics component distribution, manufacturers’ rep sales, or OEM/EMS environments

• Prior experience selling into military or aerospace sectors strongly preferred

• Strong working knowledge of electronic components (semiconductors, passives, interconnects, electromechanical, RF/microwave)

• Proven success developing accounts in a long-cycle, program-driven environment

• Understanding of Mil/Aero quality and compliance: ITAR, EAR, DFARS, AS9100, QPL/QML, traceability

• Ability to read and interpret BOMs, AVL/AML lists, datasheets, and lifecycle/obsolescence data

• Excellent communication, negotiation, and relationship-building skills

• Self-starter with strong organizational discipline and territory management capability

Collaborative team player with a customer-focused, results-driven mindset

Preferred Attributes:

• Existing relationships with defense primes, aerospace OEMs, or major Mil/Aero integrators

• Technical degree (Electrical Engineering or similar) beneficial but not required

• Familiarity with CRM systems (Salesforce, Dynamics, SAP, etc.)

• Demonstrated ability to collaborate cross-functionally with engineering and quality teams

Why Join Us:

• Competitive compensation

• Strong portfolio of franchised lines and value-added solutions

• Opportunity to influence strategic accounts in a high-growth segment

• Supportive team culture with technical resources and training

• Work with cutting-edge aerospace, defense, and advanced technology programs

Future Electronics is an equal opportunity employer.

• Serve as the technical project leader for NPI manufacturing activities, driving the development and commercialization of products.
• Provide strategic oversight of manufacturing readiness for new product introductions, ensuring alignment of engineering resources, project schedules, and cross-functional deliverables.
• Lead cross-functional collaboration with Product Development, Quality, Regulatory, Supply Chain, and Manufacturing Operations to ensure robust, scalable, and compliant processes.
• Coordinate, identify, and implement advanced manufacturing processes to ensure production capacity, efficiency, cost-effectiveness, and adherence to quality standards.
• Define project plans, timelines, and resources needed to support NPI manufacturing programs, ensuring accountability for milestones and deliverables.
• Apply in-depth technical expertise to specify, design, and validate equipment, tooling, fixtures, and automation used in production.
• Drive PFMEA, DFM/DFA, and design transfer activities to establish capable, efficient, and risk-mitigated manufacturing processes.
• Develop manufacturing assembly and test methods that ensure Critical to Quality (CTQ) and Critical to Assembly (CTA) requirements are met.
• Establish and track Key Performance Indicators (KPIs) and process capability metrics using statistical tools such as MSA, GR&R, and SPC.
• Represent externally and internally as a manufacturing subject matter expert (SME), ensuring effective knowledge transfer to production and suppliers.
• Mentor and guide junior engineers and technical staff, fostering a culture of engineering rigor, accountability, and innovation.
• Perform other tasks and duties as assigned/required.
  
  

• BS in Mechanical Engineering or related engineering discipline required.
• 10+ years of experience in an FDA/ISO-regulated medical device or medical equipment manufacturing environment.
• Are you ready to take the next step in a career that’s both challenging and deeply rewarding? If you have a background with
• Proven leadership in the selection, qualification, and scale-up of capital assembly equipment and automation.
  
  

• Advanced degree preferred.
• Demonstrated expertise in automated assembly methods, robotics, automated inspection, and fixture/tooling design.
• Strong knowledge of injection molding and plastic joining techniques (ultrasonic/RF/laser welding, adhesive/solvent bonding).
• Proficiency in SolidWorks for 3D modeling and design of assembly models, fixtures, and tooling.
• Lean Six Sigma experience and proficiency in statistical data analysis tools (Minitab or equivalent) strongly preferred.
• Strong project management skills, with demonstrated accountability for planning, execution, and delivery of NPI milestones.
• Exceptional leadership and interpersonal skills, with ability to influence and align cross-functional teams.
• Excellent verbal and written communication skills, with the ability to present technical and project information to leadership and stakeholders.
• Proven ability to thrive in a fast-paced, dynamic environment, with adaptability to shifting priorities.
• Ability to work independently with high competency, while also driving and coordinating team-based execution.
  
  

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental
• Vision
• Healthcare Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short Term Disability
• Long Term Disability
• 401K Plan
• Pet insurance
• Employee Stock Purchase Plan
  
  

A high‑growth Israel AI DLP vendor is expanding its US sales team and hiring Account Executives who are hungry, driven, and ready to help build a vibrant in‑office culture in Boston. This is an opportunity for early‑career sellers who want to accelerate fast, close real business, and be part of a founding sales team.

About the Role

We’re looking for rising stars - people with 1–3 years of closing experience who started their careers as top‑performing BDRs. You’ll step into a high‑velocity AE role where you’ll own pipeline, run your own deals, and help shape the energy and culture of a new Boston office.

What You’ll Do

• Run full‑cycle sales motions from prospecting to close
• Build and manage a healthy pipeline of net‑new opportunities
• Drive outbound activity and convert warm inbound interest
• Deliver compelling demos and value‑based conversations
• Collaborate closely with Sales Engineering, Marketing, and Leadership
• Contribute to a competitive, high‑energy, in‑office sales culture
• Help shape processes, messaging, and best practices as we scale

What We’re Looking For

• 1–2 years of AE experience at a cybersecurity vendor
• Proven success as a top BDR/SDR before moving into closing
• Strong fundamentals in outbound, qualification, and deal progression
• High energy, coachability, and a competitive mindset
• Excellent communication skills and a passion for winning
• Desire to be in the office, collaborate, and help build a team culture
• Thrives in a fast‑moving, early‑stage environment

If you're already bringing in the majority of your deals from cold prospecting, want to experience a true startup environment and commutable to Boston - I want to hear from you.

Salary: ~$220k OTE (50/50 split)

OPT Industries ( ) is a venture-backed MIT spinoff company that is focused on building the next generation of additive manufacturing technology. Working at the intersection of automation engineering, computational design, and polymer science, we design and commercially manufacture highly customizable materials and products – everything from electrical components to luxury fashion.

Position Summary: Own and improve the reliability of production equipment by troubleshooting and sustaining electromechanical, controls, and firmware-adjacent systems across OPT’s manufacturing floor.

Key Responsibilities:

• Own and develop Python-based control, test, and automation systems.
• Debug and extend ATMega embedded C/C++ (incl. hardware-software interfaces, IP networks)
• Build and maintain hardware-software interfaces for sensors, motors, actuators, and data acquisition systems.
• Design test infrastructure, logging, and fault detection to support production uptime and repeatability.
• Update equipment, documentation, training, and maintenance procedures to prevent recurrence
• Support troubleshooting and urgent production issues on aggressive timelines

Qualifications:

• 5+ years of relevant experience, or 3+ years plus a Master’s degree in robotics, mechatronics, EE, CS, or a related field.
• Strong Python background with experience in hardware control, automation, or test systems.
• Hands-on experience with electromechanical systems: motors, encoders, sensors, power electronics, and control loops.
• Working knowledge of embedded C for microcontroller-based systems
• Comfortable using Bash / Linux environments for scripting, debugging, and system operations.
• Experience supporting systems in a production or manufacturing environment is a strong plus.

OPT Industries is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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.