Engineering Structures Jobs in Woburn, MA

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.

At N-able, we're not just helping businesses be secure —we're redefining what it means to be cyber resilient. Our end-to-end platform blends AI-powered capabilities and flexible tech stacks, so customers can manage, secure, and recover with confidence. But the real power behind it all? Our people. We're a global crew of N-ablites, who love solving complex problems, sharing knowledge, and delivering solutions that actually make a difference. If you're into meaningful work, fast growth, and a team that's got your back, you'll be surrounded by people who believe in what they do—and in you.

In this role, you'll need to love the details and be a pro at bringing order to chaos. The ideal candidate will have a strong background in project and program management, executive-level stakeholder engagement, and experience leading cross-functional strategic initiatives. This person must have a strong desire and proven ability to make things happen across various teams to get them done and surface problems as early as possible. This individual plays a critical and central role in the N-able product launch process, with responsibility for managing software delivery to go-to-market plans for new products and services. This is both a strategic and tactical role for an individual who is looking to manage day-to-day activities, as well as larger, long-term initiatives for multiple projects at a time.

Success in this role requires a solid foundation to understand the Data Protection, Security, and Remote Monitoring solutions we are deploying and a relentless drive to make things happen. You will act as a strategic thought partner and advisor to leadership and will work with many N-able teams: our Product and Engineering teams, and other Go-To-Market stakeholders to create and maintain detailed project tracking and drive roll-out plans.

What You'll Do:

• Hybrid role that will sit in our Burlington, MA Collaboration Hub Tuesday through Thursday.
• Manage the project delivery stream for an N-able product function, to ensure on time, quality, delivery from concept to market.
• Develop and manage project plans, timelines, and deliverables across multiple workstreams and cross-functional teams.
• Collaborate with Marketing, Sales, Engineering, Legal, Training and other teams related to the project.
• Identify impediments and remove project barriers and blockers.
• Ensure projects are completed holistically, using documentation, training, escalation paths, etc.
• Develop and present executive-ready communications (including emails, documentation and presentations), by quantitative and qualitative insights.
• Lead and facilitate meetings, status updates, and ensure clear documentation of project progress.
• Act as a thoughtful partner to product area executive leadership to enhance the effectiveness of the team, allowing leaders to focus on high-level decision making while ensuring that operational details are managed efficiently.
• Coordinate cross-team communication to ensure alignment on strategy, messaging, and seamless execution.
• Apply your experience, knowledge and creativity to drive projects forward.
• Lead program level business unit meetings.

What You'll Bring:

• Minimum 10 years of project management experience preferably in a technology company.
• Minimum 5 years of demonstrated project management experience working with product launch teams in go-to-market projects.
• Experience in security, endpoint management, and data backup technologies a plus.
• Highly driven self-starter, motivated, with excellent communication, organization skills and the ability to influence cross-functional teams and drive results.
• Ability to effectively operate in a matrix environment in coordinating people and resources from multiple areas of the company.
• Troubleshooting and creative problem-solving skills.
• Excellent written and verbal communication skills.
• Knowledge of project management tools, techniques, and processes.
• Excellent communication and presentation skills, including experience collaborating with and presenting to senior leadership. Adept at conveying complex information in a clear and compelling manner.
• Strategic thinking with a strong bias for action—you know how to connect the dots between executive priorities and on-the-ground execution.
• Strong interpersonal skills; ability to communicate at all levels of the organization.
• Ability to manage multiple projects simultaneously.
• Demonstrated ability to structure and manage multitrack launch project plans, identifying and tracking all cross-functional workstreams.

This position has a starting base salary range of $115,000 to $132,900 per year. Actual starting pay is determined by a number of factors, including relevant skills, qualifications, and experience. This position is also eligible for bonus.

What do we offer you?

• Medical, dental and vision – for employee, partner, and children!
• Generous PTO and observed holidays
• 2 Paid VoluNteer Days per year
• Pension Plan with company-contribution
• Employee Stock Purchase Program
• Discounted gym access at several local facilities
• FuN-raising opportunities as part of our giving program
• N-ablite Learning – custom learning experience as part of our investment in you
• The Way We Work – our hybrid working model based on trust and flexibility

At N-able, our mission is to protect businesses against evolving cyberthreats with an end-to-end cyber resilience platform to manage, secure, and recover. Our scalable technology infrastructure includes AI-powered capabilities, market-leading third-party integrations, and the flexibility to employ technologies of choice—to transform workflows and deliver critical security outcomes. Our partner-first approach combines our products with experts, training, and peer-led events that empower our customers to be secure, resilient, and successful.

Clearance Requirement: Active DoD Clearance (Required)

Certification Requirement: IAT Level II certification required (or obtainable within 6 months of hire)

Position Overview

We are seeking a motivated Cloud Systems Engineer . This entry-level engineering role focuses on ensuring stability, scalability, and reliability of cloud-based systems supporting mission-critical applications.

The selected candidate will collaborate with senior engineering teams to support cloud platforms, assist with system integration activities, and maintain distributed virtual environments operating within secure enterprise networks.

Key Responsibilities

• Support stability, sustainability, and performance of enterprise cloud-based infrastructure and software systems
• Assist in system integration, verification, validation, and operational support activities
• Monitor and maintain distributed virtual machine environments across cloud platforms
• Implement proactive engineering mechanisms to maintain system health and availability
• Perform functional analysis, system evaluations, and technical trade studies
• Troubleshoot system performance, configuration, and operational issues
• Develop and maintain technical documentation, procedures, and runbooks
• Collaborate with engineering teams to improve automation and operational efficiency
• Ensure compliance with DoD cybersecurity standards and operational requirements
• Participate in continuous learning and technical development initiatives

Required Qualifications

• Bachelor's degree in computer science, Information Technology, Systems Engineering, or related field
• 1–2 year of experience in cloud systems, IT infrastructure, or systems engineering
• Active DoD Security Clearance (required at time of hire)
• Basic knowledge of cloud platforms such as AWS, Microsoft Azure, or Google Cloud Platform
• Understanding of Windows or Linux operating systems
• Knowledge of networking fundamentals and virtualization concepts
• Strong analytical and problem-solving skills
• Ability to work effectively in a team-oriented DoD environment
• U.S. Citizenship required

Certification Requirements

• DoD IAT Level II Certification (Security+ CE or equivalent)
• Minimum one cloud certification within 6 months of hire, such as:
• AWS Certified Cloud Practitioner / Solutions Architect Associate
• Microsoft Azure Fundamentals / Azure Administrator
• Google Associate Cloud Engineer

Preferred Qualifications

• Internship or academic experience supporting cloud or infrastructure environments
• Exposure to VMware, Hyper-V, or virtualized environments
• Basic scripting experience (PowerShell, Python, or Bash)
• Familiarity with automation or Infrastructure-as-Code concepts
• Experience supporting Federal or DoD programs

Our client is a global leader within nutrition, health and beauty. For their facility in Lexington, MA they are looking to hire an Associate Principal Scientist, Fermentation. This role will be responsible for fermentation science on a global basis. As head of the bioprocess team, you will link activities in fermentation and downstream recovery technologies.

The role will manage a team of scientists in the bioprocess sciences team, as well as lead close interactions with the microbiome team and other global R&D and pilot plants.

The Role

• Drive continuous improvement of methods, experimental setups, and workflows across R&D teams.
• Mentor, coach, and empower a diverse team of Scientists and Engineers, fostering an inclusive environment where all voices are values. Serve as a problem-solving consultant to internal and external project team members, including laboratory and biomanufacturing personnel.
• Lead communications with internal collaborators, third parties, and strategic partners.
• Work closely with the Lexington Strain Engineering Team and Microbiome Team to direct the development and implementation of (an)aerobic fermentation protocols to identify improved organisms and develop novel processes. Coordinate cross‑site experiments and knowledge transfer; clearly communicate progress and risks to stakeholders.
• Ensure compliance to quality, environmental, occupational health & safety procedures; uphold aseptic techniques and contamination control. Promote a positive, safe and compliant work environment.
• Work setting: Lab‑based leadership role with hands‑on experimentation and on‑the‑shopfloor coaching.

The Requirements

• PhD plus 8 years of experience or MSc plus 12 years of experience in Fermentation Science, Biotechnology, Biochemical Engineering, Metabolic Engineering, Microbiology, or related field - or equivalent industry experience.
• Extensive experience with bench scale (10 ml to 10 L) anaerobic and aerobic microbial fermentation equipment and technology leveraging yeast, fungi, and bacteria.
• Understanding of scale-up / scale-down of fermentation and downstream recovery operations.
• Broad microbial physiology and gut microbiome research expertise is a strong plus.
• Previous industry and direct team leadership experience with excellent project management and organizational skills (Minimum 5 years of team leadership required).
• Background collaborating with strain engineering and analytical chemistry teams (omics, modelling, protein engineering) to translate strain capabilities into bioprocess wins.

AgZen’s mission is to make agrochemical spraying more efficient and eliminate pesticide waste. Our products allow farmers to use up to 50% less agrochemicals while improving pest control, crop health, and yield. We are a vibrant startup based in Boston, Massachusetts, and we are committed to helping farmers save money and preventing the over-spraying of agrochemicals.

Founded out of MIT and backed by $13.5M in funding from DCVC and Material Impact, our multidisciplinary team of engineers and scientists is redefining sustainable farming with breakthrough technology. We’re not just improving agriculture, we’re reimagining what’s possible.

About the Role:

The Product Management team is responsible for defining, developing, and scaling AgZen’s product line that combines sensing, computer vision, and data analysis to fundamentally improve spraying. The team works across hardware, software, and field operations to ensure products meet performance goals and deliver measurable impact for growers.

As a Product Manager, you will guide the roadmap and execution of AgZen’s RealCoverage system and related spray optimization products. You will translate customer needs, technical constraints, and business priorities into clear direction for cross-functional teams, helping AgZen bring reliable, high-performing products to market at scale.

This role is located in Somerville, MA (Boston area) with work required to be in-person. 

What You’ll Do:

• Define and manage the roadmap for RealCoverage and future spray optimization products.
• Translate customer and field insights into product requirements and priorities.
• Collaborate with engineering on specifications, trade-offs, and release planning.
• Partner with field operations and commercial teams to validate performance and usability in real-world conditions.
• Guide product evolution from real-time measurement toward predictive and prescriptive capabilities.
• Support scaling efforts as AgZen transitions from pilot to large-scale commercial deployments.
• Communicate product goals, progress, and dependencies across engineering, field, and business teams.

What We're Looking For:

• Bachelor’s degree in engineering, computer science, or a related technical field preferred.
• 5+ years of experience as a Product Manager or Technical Program Manager in robotics, autonomous systems, or other hardware/software products.
• Strong technical understanding of sensing, embedded systems, and AI/ML development.
• Proven ability to manage technically complex products and balance customer, technical, and business needs.
• Experience collaborating with cross-functional teams, including engineering and field operations.
• Comfortable working in both lab and field environments and adjusting to real-world constraints.
• Strong organizational and communication skills; able to work independently in a fast-paced, early-stage company.
• Familiarity with agriculture, agtech, or industrial systems is a plus.

What we offer: The opportunity to make an immediate and visible impact in a fast-growing company, competitive salaries, early-employee equity, 401(k) with employer matching, generous PTO and paid holidays, health, dental, and vision insurance.

We are seeking a Chief Engineer to join our dynamic team at Flagship Facility Services LLC. In this pivotal role, you will oversee engineering operations and ensure the highest standards of facility maintenance and management. Your leadership will be crucial in delivering exceptional service to our clients while driving operational efficiency. The Chief Engineer must ensure the highest level of professionalism, while meeting the clients’ needs, and a commitment to achieving the goal of 100% uptime throughout the engineering team.

Responsibilities

• Supervise the performance and maintenance of all mechanical, electrical and craft services, ensuring operation within design capabilities and achieving proper environmental conditions prescribed by Building Management.
• Oversee and supervise the efficient operation of the facility equipment and systems.
• Perform requisite daily communication with Building Management on matters relating to the services performed.
• Develop operating instructions and procedures for equipment and systems. Strive toward a goal of zero down-time in operations by virtue of reliable system performance.
• Prepare operating budgets relative to the Engineering Department.
• Together with the Flagship Branch Manager, implement and conduct training programs for operating the facility equipment and systems.
• Establish and maintain periodic operational testing schedules for critical systems and equipment.
• Administer an effective and accountable preventative maintenance system tailored to the facility.
• Evaluate all equipment and systems operationally and provide the customer with a list of deficiency items and recommendations for improvement.
• Monitor and supervise subcontracted jobs to outside concerns when it is not practical for them to be performed in-house, or as may be requested by Building Management.
• Monitor an effective energy conservation and management program to ensure measures are taken to keep operating costs at a minimum.
• Possess the requisite licenses and permits required by local laws and ordinances to operate, repair and maintain the facility equipment and systems. Ensure that the on-site staff conforms to all local laws, codes and regulations. In conjunction with Building Management, establish a program for the acquisition, storage and accountability of all operating materials, tools and equipment.
• Establish a customer approved inventory control system.
• Support and maintain a work order system for the control and assignment of all on-call and unscheduled services requested by the customer.
• This system is to include the work performed, where applied, personnel assignments, time and material estimates, and authorization.
• Ensure that work responsibilities are allocated properly among subordinates by developing and implementing manpower schedules and work methods and procedures that are designed to obtain low cost and efficient operation.
• Establish performance standards for each phase of work, adhering to standard practices and quality levels.
• Carry out policies and procedures of the customer and Flagship Facility Services, Inc. concerning safety, administrative requirements, standards, practices and work methods.
• Perform any additional duties on an as required basis where such duties are within the scope of contractual limitations.
• Minimum of five (4) years’ experience in the implementation of the above.

Knowledge and Skills

• Central Plant Experience
• Mission critical facility experience- data center, hospital, science labs
• Manages all maintenance, capital, and technical projects
• Liaisons with engineers, consultants, and architects
• Working knowledge of MEP systems, building, fire, mechanical, and electrical codes
• Ability to read and interpret blueprints, schematics, technical manuals, and one-line diagrams
• Able to troubleshoot and repair motors, pumps, valves, lifts, and generators
• Working knowledge of fire alarm and suppression systems
• Electrical, hydraulic, mechanical power transmission, and pneumatic systems knowledge
• Ability to write scopes of work, method of procedures, and job safety analysis
• Acts as site EHS lead
• OSHA 10 mandatory, OSHA 30 preferred
• Ability to manage budgets and key performance indicators (KPIs)
• Ability to perform root cause analysis
• Advance knowledge of building automation systems
• Working knowledge of computerized maintenance management (CMMS) and energy management systems

Education and work experience

• Associates technical degree required, Bachelors preferred
• Must have Boiler Operator I License
• Must have Waste Water License
• Licensed HVAC, Plumbing or Electrical preferred

If you are ready to take your career to the next level as a Chief Engineer with Flagship Facility Services LLC, we invite you to apply today and be part of our commitment to excellence in facility services!

Benefits:

• Design and develop PLC, HMI, control programs for automated packaging machinery (Rockwell, Siemens)
• Support equipment startup, debugging, and commissioning at the facility and occasionally at field sites
• Provide troubleshooting support to assembly teams and field service technicians for electrical and software-related issues and develop system upgrades, enhancements, and solutions for field-reported issues
• Collaborate with engineering and project management to support project schedules and machine build timelines
• Deliver documentation for designs as well as training and work instructions for field operation

• 3+ years of experience in automation, controls engineering, or machinery manufacturing
• Hands-on experience with PLCs (Rockwell, Siemens) and python
• Develop and maintain python utilities used in robot operation, deployment, and debug environments.