Engineering Structures Jobs in Somerville, MA

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.

Pay: $65,000.00 - $96,000.00 per year

Job description: Manufacturing Engineer 

Please apply if you have hands-on experience in taking a design concept and successfully preparing it for large-scale production. In addition, you’ll need experience with one of the following: mechanical prototyping with injection molding, CNC machining, thermoforming, plastic extrusion, or blow molding.

This is a hands-on role, perfect for someone who enjoys rolling up their sleeves, solving complex problems, and helping take innovative designs all the way to scalable production.

This is not a management-track position. 

What You’ll Do:

• Design efficient and scalable manufacturing processes
• Optimize production workflows and resolve bottlenecks
• Select, evaluate, and implement manufacturing equipment
• Support inventory and materials management
• Collaborate closely with cross-functional engineering, operations, and mechanical teams
• Bring prototypes into large-scale manufacturing
• Lead hands-on prototyping efforts when necessary
• Work extended hours when needed to meet critical deadlines

Required Experience & Skills:

• Previous experience as a Manufacturing Engineer
• Strong background in manufacturing processes and production optimization
• Demonstrated experience taking a design from prototype to high-volume manufacturing
• Experience with DFM/DFMA
• Ability to collaborate effectively with engineers, technicians, and operators
• A proactive, problem-solving mindset and willingness to jump into challenges

* Please note that U.S. citizenship or lawful permanent resident status is required due to federal contract requirements.

What We Offer

• 3 weeks paid time off
• Sick pay & parental leave
• 10 paid holidays
• Health and dental insurance
• 401(k) match

Job Type: Full-time

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.

Responsibilities 

• Support MAP manufacturing and process development for the Platform Research team.
• Work cross-functionally with formulation/analytical and preclinical teams to identify novel candidates for  development on the MAP platform, build platform flexibility and utility.  
• Develop and document batch records and test methods to characterize and support MAP formulation and  process development; identify opportunities for process improvement.  
• Thoroughly document MAP manufacturing process parameters, analyze data and trends, and effectively  communicate results through technical presentations and written reports.  
• Support early collaborations with strategic partners by generating proof-of-concept data packages.
• Interface with manufacturing and automation teams to share learnings and support platform improvement.
• Assist with the design and testing of new fixtures, tooling, and equipment to improve process throughput and  consistency.  

Qualifications 

• BS or MS in Biomedical, Chemical, or Mechanical Engineering, or related discipline with 0-2+ years of R&D  biotech or medical device experience.  
• Prior industry experience with novel platform and process development is preferred.  
• Familiarity with imaging and physical characterization techniques is a plus.  
• Experience with programming and prototyping/3D printing is a plus.  
• Experience with GxP is a plus.  
• Strong attention to detail. Ability to identify root causes of problems and recommend corrective actions.
• Excellent verbal and written communication skills. 
• Demonstrated abilities to learn new skills and fields, solve challenging technical problems, think independently,  and work collaboratively in cross-functional teams 
• Entrepreneurial spirit and drive to positively impact public 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

Senior Technical Support Engineer

Location: San Francisco, CA | Raleigh, NC | Dallas, TX | Boston, MA

Schedule: Hybrid – 3 days onsite required

Employment Type: 6-Month Contract-to-Hire

Pay Rate: $65–68/hour

Start Date: ASAP

About the Role

The Technical Solutions team is focused on advancing care and research innovation. We support new business initiatives by expanding product capabilities in strategic areas and delivering a scalable technical support framework across multiple product portfolios.

As a Senior Technical Support Engineer, you will partner closely with internal stakeholders to identify, reproduce, troubleshoot, and resolve complex technical issues. You will support infrastructure, permissions, and configuration changes while delivering high-level technical support and sustaining engineering services that help customers achieve meaningful business outcomes.

This role offers the opportunity to collaborate with customers, developers, architects, and operations teams to solve challenging, high-impact problems. You will also contribute to building support tooling and infrastructure to improve operational efficiency.

Travel up to 10% may be required.

Key Responsibilities

• Own and manage technical customer issues from identification through full resolution
• Reproduce and troubleshoot complex technical problems, including reviewing and analyzing code to determine root cause
• Project manage new client deployment issues through to completion
• Implement infrastructure, security, and permissions configuration changes
• Drive operational efficiencies by identifying improvements in process, tooling, and product functionality
• Develop playbooks and knowledge base documentation to streamline issue resolution
• Create internal reports and dashboards for issue tracking and performance monitoring

Minimum Qualifications

• Bachelor’s degree in Computer Science, Information Systems, Mathematics, Statistics, or related field
• Cloud operations experience (creating buckets, virtual machines, and managing security access controls/IAM)
• 3+ years of experience with Python or another object-oriented programming language
• 3+ years of experience working with SQL
• Experience troubleshooting data-related issues
• Proficiency with GitHub and Jira
• Strong troubleshooting skills with the ability to track complex technical details
• Excellent communication skills with the ability to translate technical findings for both senior developers and non-technical stakeholders

Preferred Qualifications

• 4+ years of experience in healthcare technology
• Experience supporting highly regulated software environments
• Experience with R
• Infrastructure-as-Code (IaC) experience such as Terraform, Ansible, or similar tools
• Self-starter mindset with strong ownership and a passion for driving issues through to resolution

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

Immediate need for a talented Scientist I. This is a 12+ Months contract opportunity with long-term potential and is located in Waltham, MA, USA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-08545

Pay Range: $ 46-$56 /hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
• Lead and conduct viral/non-viral vector purification process development and process analytics
• Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
• Develop, conduct, maintain analytical assays such as ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS etc. for in-process sample testing to support process development
• Provide scientific and technical expertise for in-process sample testing activities, including product quality and process impurity methodologies
• Perform troubleshooting experiments and communicate findings with appropriate working groups
• Maintain industry knowledge and keep abreast of new and relevant technologies
• Perform data analysis, contribute to technical reports, external publications, patent applications and internal/external presentations
• Lead scale-up activities to implement a manufacturing process based on DSP development knowledge
• Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities
• Mentor and support junior staff and build a culture of support and collaboration

Key Requirements and Technology Experience:

• Key skills: - Purification experience/ Protein Purification Chromatography
• Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, - Late-stage purification experience such as design space mapping and process robustness studies
• PhD in Biotechnology, Biochemistry, Chemical Engineering or related discipline or master’s degree with a minimum of 4 years of relevant experience or a bachelor’s degree with a minimum of 6 years of relevant experience
• Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS
• Significant experience, knowledge and understanding of purification technologies and operations such as:
• Filtration unit operations at various scales, including depth filtration, tangential flow filtration, etc.
• Protein purification chromatography
• Virus clearance and inactivation
• Familiarity with advanced purification technologies and process analytical technologies
• Familiarity with analytical method transfer, analytical method bridging across organizations
• Experience with process technology transfers and performing gap analyses and risk assessments
• Understanding of critical quality attributes and the principles of Quality by Design and ability to apply DOE to downstream development
• Expertise in technical report writing
• Experience in AAV and/or non-viral purification development
• Experience in writing CMC components of regulatory dossiers
• Knowledge of product comparability, target product profile and quality risk assessment activities
• Viral clearance study design and execution
• Late-stage purification experience such as design space mapping and process robustness studies
• Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs)
• Ability to work under minimal supervision and function within a collaborative, team-oriented environment
• Excellent organization and communication skills
• Innovative, critical and creative thinker, unafraid of proposing aggressive solutions to complex problems
• Experience with biophysical characterization
• Experience in continuous manufacturing and process analytical technology
• Experience in mentoring junior staff
• Ability to build and nurture cross-functional relationships
• Ability to communicate and represent group in diverse, multi-functional meetings

Our client is a leading Pharmaceuticals industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

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