Engineering Journal Jobs in Middlesex Massachusetts

About the Role

We’re looking for a Quality Director to lead and evolve our quality function as we scale regulated medical devices that incorporate AI/ML software. This role sits at the intersection of hardware, software, and data science and will be critical in ensuring our products meet regulatory requirements while maintaining development velocity.

You’ll report to the VP of Quality & Regulatory and work closely with Engineering, Regulatory, Clinical, and Operations. The right person for this role is comfortable in a fast-moving environment and knows how to build practical, right-sized quality systems.

What You’ll Do

Lead the Quality Function

• Own and continuously improve our Quality Management System (QMS)
• Lead and develop a small but growing quality team
• Establish KPIs and reporting for executive leadership
• Serve as the quality voice at the leadership table

Ensure Regulatory Compliance

• Maintain compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR
• Prepare for and lead FDA inspections, ISO surveillance audits, and notified body audits
• Support regulatory submissions from a quality perspective
• Monitor evolving FDA guidance on AI/ML-enabled devices and ensure alignment

Support Product Development

• Embed Design Controls into hardware and software development processes
• Ensure compliance with IEC 62304 for software lifecycle processes
• Oversee risk management activities (ISO 14971), including FMEA and hazard analysis
• Partner with Data Science teams on AI model lifecycle controls (training data management, model updates, change control, performance monitoring)

Post-Market & CAPA

• Oversee complaint handling, MDR reporting, and CAPA processes
• Drive investigations and ensure root cause analyses are thorough and actionable
• Use data trending to proactively identify quality risks

Supplier & Manufacturing Quality

• Establish and maintain supplier qualification and audit processes
• Oversee incoming inspection and production quality controls
• Partner with Operations to ensure scalable manufacturing processes

What you'll do

Experience

• 10+ years in quality roles within medical devices or regulated healthcare software
• At least 3–5 years in a leadership capacity
• Direct experience with FDA inspections and ISO 13485 audits
• Experience supporting both hardware and software products
• Familiarity with AI/ML in a regulated environment strongly preferred

Technical Knowledge

• Deep understanding of:
• FDA QSR (21 CFR 820) and ISO 13485
• ISO 14971 risk management
• IEC 62304 software lifecycle requirements
• Working knowledge of Agile/Scrum environments
• Comfort reviewing technical documentation and working closely with engineers and data scientists

Leadership Style

• Hands-on and pragmatic
• Comfortable operating in ambiguity and growth environments
• Able to push back when needed
• Strong communicator with auditors, executives, and technical teams

Nice to Have

• Experience with Software as a Medical Device (SaMD)
• Background in AI/ML model governance or data quality controls
• ASQ certification (CQE, CMQ/OE, etc.)
• Prior experience in venture-backed or scaling organizations

*2nd shift, 3-11pm*

Job Summary

The Manufacturing Supervisor provides hands-on leadership of second shift GMP manufacturing operations for microbiome Live Biologic Products. This role supervises four contract associates and ensures safe, compliant, and efficient execution of fermentation, harvest, lyophilization, media/buffer preparation, packaging, and suite readiness activities. The Supervisor serves as the primary on-site manufacturing leader during second shift and actively supports floor operations.

Responsibilities

• Supervise second shift GMP manufacturing activities, including fermentation and downstream processing.
• Lead and support four contract manufacturing associates; assign tasks and provide coaching.
• Ensure production suites, equipment, and materials are ready and compliant.
• Enforce cGMP, safety, and quality standards.
• Review batch records and documentation for accuracy and completeness.
• Execute shift schedules to meet production timelines.
• Escalate and support resolution of manufacturing issues, deviations, CAPAs, and change controls.
• Support new processes, SOP implementation, and technology transfers.
• Provide clear shift handovers and communicate production status and risks.

Qualifications

• Bachelor’s degree in Biology, Biochemistry, Engineering, or related field preferred.
• 3–6 years of GMP manufacturing experience; prior supervisory or lead experience preferred.
• Experience with fermentation, microbial processing, aseptic techniques, or lyophilization preferred.
• Strong knowledge of cGMP regulations and documentation practices.
• Experience reviewing batch records and supporting deviation management.

W-2 employees only. No 3rd parties.

• 8+ years in Technical Program Management, Digital Transformation, or Engineering Program Delivery.
• 3+ years leading AI/ML or advanced analytics initiatives.
• Experience in regulated industries (Pharma, Biotech, Medical Devices).
• Strong understanding of AI/ML lifecycle and data governance.
• Experience working with enterprise platforms (LIMS, MES, SAP, Veeva, etc.).
• Strong stakeholder management and executive communication skills.

Salary Range: 65k-95k

Title: Materials Management Specialist/Senior Materials Management Specialist

Location: Woburn, MA (on-site 5 days per week)

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role: 

Works under the operations team and in coordination with the Quality Assurance (QA) team to oversee the entire flow of materials, from procurement and inventory control to receipt to storage and distribution. Ensure all materials meet defined specifications and are available for intended use and quantities to support user needs. Provide continuous improvement efforts in purchasing, planning, and warehousing. Key responsibilities include strategic sourcing, inventory optimization, demand forecasting, supplier negotiation, and managing logistics for clinical distribution while reducing waste and costs.

Responsibilities: 

• Develop material strategies, forecasts demand, plans production and inspection schedules, and aligns material flow with business goals.
• Maintains optimal inventory levels, conducts physical counts, investigates discrepancies, and implements lean manufacturing principles.
• Supervises purchasing, inventory, and warehouse activities in a manner consistent with cGMPs.
• Assists Quality Assurance to assign and document the status for all materials used in the development of Vaxess products.
• Implements initiatives to reduce waste, cost efficiencies, and improve financial performance.
• Sources, negotiates, and purchases goods and services, building strong supplier relationships and ensuring quality and reliability.

Qualifications: 

• 2 to 5 years in Material Management or Shipping and Receiving in the Pharmaceutical or Medical Device Industries working in a cGMP Environment.
• Strong understanding of supply chain, logistics, and inventory principles.
• Experience with ERP Systems/SAP preferred.
• Experience with standard cGMP storage requirements for Quarantine, Release and Rejected materials.
• Experience with the receipt, storage, distribution, and shipping of temperature-controlled materials.
• Bachelor’s Degree in a relevant field (Logistics, Biomedical Engineering or Health Care Management and certifications (APICS, ISM) preferred.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to   

Salary range: 60k - 80k

Title: Operations Associate, Facilities

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

Research & development at Vaxess is cross-disciplinary, integrating mechanical, industrial, biomedical, and

chemical engineering with chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated engineer to join our growing team. This role offers a unique opportunity to build manufacturing capacity from the ground up to bring innovative technology to the global vaccine and therapeutic market. Vaxess Manufacturing Tour

Responsibilities

• Provide support for the overall lab environment, ensuring proper functioning of utilities, lab equipment and life
• safety systems
• Perform facility & safety inspections including chemical, biological and universal waste consolidation
• Perform equipment installations, qualifications and calibrations for lab & facility equipment/casework
• Provide support to various facilities administration duties including but not limited to external vendor
• coordination, landlord services, HVAC, plumbing, etc.
• Provide support to consumable, chemical and off-site storage inventories
• Collaborate closely with cross-functional teams to support product development and manufacturing activities
• Maintain necessary certifications DOT, RCRA, Bloodborne Pathogens, etc.

Qualifications

• 2-4 years’ experience as on-site technician working in an industrial R&D, Quality Control or Manufacturing lab
• Highschool Diploma/GED is required, BS in STEM degree is a plus
• Ability to lift 50 Lbs. & work across multiple sites
• Familiarity with Lab standards, compressed gas and laboratory utilities, generators, HVAC, IT & access control
• Familiarity or experience working in GxP, a cleanroom and/or a biomedical laboratory environment
• Excellent time and project management skills and proven ability to meet goals and deadlines
• Demonstrated ability to build, repair and maintain equipment, fixtures and furniture
• Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think
• independently, and work collaboratively in diverse multidisciplinary teams
• Entrepreneurial spirit and drive to positively impact global human health

Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you’re interested in joining the Vaxess team, please submit your CV/resume to

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role

We are seeking a motivated and detail-oriented Research Associate with strong hands-on experience in chromatographic analysis to support QC release and stability testing. The successful candidate will perform routine cGMP QC testing using HPLC methods (RP-HPLC, SEC, IEX), Agilent HPLC systems, and additional supporting assays in a fast-paced, collaborative environment. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

• Perform routine QC release and stability testing using HPLC methods including RP-HPLC, SEC, and IEX.
• Prepare samples, operate Agilent HPLC systems, verify system suitability, and ensure analyses meet method and specification requirements.
• Execute complementary analytical assays such as UV-Vis, pH, surface tension, and mechanical tests.
• Maintain complete, accurate documentation in compliance with cGMP, ALCOA+, and data integrity requirements.
• Conduct routine instrument care (solvent flushes, column care, daily checks) and assist troubleshooting under supervision.
• Process and review chromatographic data in Agilent OpenLab CDS.
• Support method qualification, validation, and transfer activities by executing protocols and recording observations.
• Maintain calibration, maintenance, and service records for analytical instrumentation.
• Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
• Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success.
• Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
• Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related field with 1–3 years of experience; or a master’s degree with relevant laboratory experience.
• Hands-on experience operating HPLC systems; Agilent systems and OpenLab CDS experience strongly preferred.
• Practical experience with chromatographic techniques including RP-HPLC, SEC, and IEX.
• Experience supporting QC release or stability testing in a GMP/GLP environment.
• Strong attention to detail and ability to follow SOPs precisely.
• Excellent documentation practices and understanding of data integrity.
• Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment.
• Excellent verbal and written communication skills and comfort working within interdisciplinary teams.
• Commitment to collaborative work within interdisciplinary project teams.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to

About the Role

The ideal candidate has hands-on experience in Cesium chloride (CsCl) density gradient ultracentrifugation, ion-exchange chromatography, affinity purification, and tangential flow filtration (TFF), with a strong understanding of purification principles and data analysis.

Responsibilities

• Execute purification processes including CsCl density gradient ultracentrifugation, affinity chromatography (e.g., AVB, CaptureSelect), ion-exchange chromatography (AEX, CEX), and other polishing steps.
• Operate AKTA systems (Avant, Pure, or Pilot) for small- to large-scale purification runs.
• Perform TFF operations for buffer exchange and concentration of intermediate or final products.
• Support experimental design, data collection, and documentation following established procedures and GMP/GLP best practices.
• Assist in troubleshooting and optimization of purification processes.
• Analyze in-process and purified samples using relevant analytical methods (e.g., UV, SDS-PAGE, ddPCR, ELISA, or HPLC).
• Collaborate cross-functionally with upstream, analytical, and manufacturing teams.
• Maintain lab equipment, manage buffers and column inventory, and ensure compliance with safety and documentation standards.

Qualifications

• Education: Master’s degree in biology, biochemistry, chemical engineering, biotechnology, or related field.
• Experience: Minimum 2 years of hands-on purification experience in an academic or industry setting.

Required Skills

• Strong knowledge and practical experience with CsCl density gradient ultracentrifugation, ion-exchange, and affinity chromatography.
• Familiarity with buffer preparation.
• Understanding of basic analytical methods for product characterization.

Preferred Skills

• Strong attention to detail and excellent documentation habits.
• Effective communication and teamwork skills.
• Ability to manage multiple tasks and meet project timelines.

Preferred Qualifications

• Experience in AAV or other viral vector CsCl density gradient and column purification.
• Experience with AKTA systems and Unicorn software.

Salary Range: 72-114k

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Electrical Control Engineer designs, develops, programs, and maintains automated control systems used in industrial, manufacturing, or infrastructure environments. The role focuses on improving system efficiency, reliability, and safety through PLCs, machine vision, HMIs, robotics, and industrial networks.

Responsibilities:

• This is a hands-on position involving designing, building, and troubleshooting automated equipment.
• Design and maintain novel automated systems and solutions that contribute to current manufacturing and scale up of manufacturing operations to eventual commercialization.
• Project management of electrical and controls projects.
• Design control schemes, circuits, power distribution, high/low voltage, electrical panels, and layouts. 
• Document electrical schematics and BOMs and contribute to assembly and installation of systems.
• Develop and optimize machine vision inspection equipment, lighting, optics, and code.
• Troubleshoot electrical and control issues to contribute to root cause analysis and develop timely solutions for production problems that might arise.
• Contribute to continuous improvement to increase safety, quality, and efficiency of manufacturing.
• Draft maintenance SOPs and contribute to implementation and maintenance of the Quality System.
• Draft equipment requirements and work closely with external vendors to develop plans and evaluate proposals, and manage external projects.
• Collaborate closely with cross-functional teams to support product development and manufacturing activities.

Qualifications:

• BS or MS in Electrical Engineering or a related discipline.
• 3-5 years of high volume medical device or pharmaceuticals manufacturing or related experience.
• CAD (SolidWorks or similar) for electrical schematics and drawings
• Familiarity or experience working with machine vision (OpenCV, Cognex Pro, or similar), motion control and PLC & HMI platforms (Rockwell/Allen-Bradley or similar), general programming (Studio 5000, Python, C++, or similar)
• Excellent time and project management skills and proven ability to meet goals and deadlines.
• Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams.
• Entrepreneurial spirit and drive to positively impact global human health.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value

collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to

Salary Range: 62k - 96k

Title: Research Associate/Senior Research Associate, Preclinical

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

Research & development at Vaxess is cross-disciplinary, integrating basic science and engineering to transform delivery of next-generation therapies and vaccines. We are seeking a talented, collaborative, and highly motivated individual with expertise in translational animal models to join our core team of preclinical scientists and engineers. This is a unique opportunity to be part of an emerging early phase clinical company bringing innovative microneedle therapeutic delivery technology to the global market.

Responsibilities:

• Support in vivo studies, including PK and safety studies in swine. This includes preclinical animal model development and IND-enabling safety and efficacy studies across pipeline programs.
• Emphasis will be placed on coordination and participation in survival PK studies in swine
• Track ongoing animal studies, coordinating tasks from vivarium organization and test article administration to tissue harvest and downstream processing
• Ensure timely and thorough documentation of processes and learnings following in vivo studies, with an emphasis on longitudinal tracking of outcomes and compiled data summaries
• Characterize microneedle array patch (MAP) test articles deployed into preclinical models, e.g. by visual inspection, skin penetration, dose delivery and potentially other performance measurements
• Perform initial biometric tests on animals and downstream blood and tissue harvests to support bioassays that assess treatment effects
• Contribute to study design and protocol and report writing; communicate logistical needs and present work in team meetings
• Collaborate closely with scientists and engineers to advance drug candidates from research through Phase I/II clinical trials
• Maintain accurate laboratory records and electronic lab notebook entries
• Travel to testing facilities in the greater Boston area, potentially several times per week; transport test articles and equipment as needed.

Qualifications:

• Bachelor’s degree in one of the Life Sciences with at least 2 years of related work experience OR Master’s degree in one of the Life Sciences with 0-2+ years of related work experience
• Experience with large animal handling and technical procedures, particularly swine, is required; Experience with large animal research models and PK studies is considered a plus
• Strong organizational skills and attention to detail
• Excellent verbal and written communication skills
• Committed to working collaboratively with an interdisciplinary team

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to  

Location: Boston + Somerville, MA

Type: Full-time

Reports to: Project Manager and VP of Real Estate

Role Summary

Rafi Properties is seeking an Assistant Construction Project Manager (ACPM) to support planning, coordinating, and executing construction projects from pre-construction through completion. This role ensures that projects are completed on time, within budget, and in compliance with safety and quality standards. The ACPM acts as a liaison between stakeholders, tenants, subcontractors, vendors, and on-site personnel. 

Key Responsibilities:

Project Planning & Coordination

• Assist in developing and maintaining project schedules and work plans.
• Coordinate with architects, engineers, consultants, and contractors to ensure timely delivery of project milestones.
• Organize and attend project meetings, record minutes, and follow up on action items.

Documentation & Reporting

• Manage project documentation, including contracts, RFIs, submittals, change orders, and drawings.
• Maintain up-to-date records of daily progress reports, meeting notes, and project correspondence.
• Track and update project budgets and cost reports in collaboration with the Project Manager.

Procurement & Vendor Management

• Assist in sourcing and procuring materials, equipment, and subcontractor services.
• Issue purchase orders and manage vendor/subcontractor invoices in accordance with budget.
• Follow up with suppliers and subcontractors to ensure timely delivery of goods and services.

Site Coordination & Quality Control

• Conduct regular site visits to monitor progress, safety, and quality control.
• Work with superintendents and site supervisors to resolve on-site issues.
• Ensure adherence to safety regulations and company policies.

Risk Management

• Identify potential issues or delays and work with the Project Manager to resolve them.
• Assist in preparing and implementing risk mitigation plans.

Qualifications:

Education & Experience

• Bachelor’s degree in Construction Management, Civil Engineering, or related field preferred.
• 3–5 years of experience in construction project coordination or management.
• Experience in construction and owner’s project management is a plus.
• Up to 60% travel required from site-to-site as required by projects.
• Valid driver’s license required.

Skills & Competencies

• Strong organizational and time-management skills.
• Excellent written and verbal communication.
• Ability to read, interpret, and value-engineer construction drawings and specifications.
• Proficiency in construction management software (e.g., Procore, Buildertrend, MS Project) and MS Office Suite.
• Familiarity with construction contracts (AIA, GMP, etc.) is a plus.

Why Rafi Properties 

Rafi is a global real estate owner, operator and investor with HQ in Boston and Hong Kong. We believe today’s market rewards those who can think institutionally while acting nimbly. We move with urgency when opportunity presents itself and exercise patience when long-term value demands it. In a rapidly changing world, flexibility, discipline, and a long-term mindset are core to how we create alpha — and to the people we look to build with us.

Interested candidates should submit resumes to: