Engineering Structures Jobs in Woburn

Role: AV Manager (Autonomous Vehicle Operations Manager)

Location: Washington, D.C.

The AV Manager will oversee daily operational activities for the Autonomous Vehicle (AV) Drive Operations Program across designated city sites. This role ensures smooth field operations, compliance with safety standards, quality of service delivery, and team performance. The AV Manager will work closely with local and regional leaders to ensure efficient deployment of AV fleets and consistent driver/operator management.

Key Responsibilities

• Lead, coordinate, and manage AV Driver/Operator teams across assigned locations.
• Conduct daily shift planning, scheduling, task delegation, and attendance tracking.
• Ensure compliance with all safety, security, and operational protocols.
• Train, coach, and mentor new and existing AV operators on operational procedures and program standards.
• Conduct performance reviews, provide feedback, and manage disciplinary actions when required.
• Collaborate with cross-functional teams (Operations, Fleet, Safety, Engineering) to ensure vehicle readiness and resolve operational issues.
• Monitor site productivity metrics and implement improvements to enhance efficiency.
• Respond to on-ground escalations and operational emergencies promptly.
• Prepare weekly operational status reports and performance summaries.
• Coordinate with Fleet & Maintenance teams to ensure optimal vehicle uptime.

Qualifications

• 5+ years of experience in Operations, Transportation, Logistics, Automotive, or related field.
• Prior experience in a managing or lead role managing teams.
• Strong understanding of safety protocols and compliance-driven environments.
• Excellent communication, leadership, and people management skills.
• Ability to analyze performance metrics and identify process improvement opportunities.
• Comfortable working in dynamic and fast-paced field settings.
• Valid driver's license with a clean driving record.
• Ability to travel between assigned cities as needed.

Preferred Skills

• Experience working with autonomous vehicles, fleet operations, or mobility transportation programs.
• Knowledge of incident reporting, compliance documentation, and operational audits.
• Technical aptitude to understand basic AV system operations and diagnostics

Work Environment

• On-site operations environment; may require early mornings, late evenings, weekends, or split shifts based on program schedules.
• Field-based work involving both indoor and outdoor environments.
• Significant travel required - approximately 90% of the time across locations.

About ProcDNA:

ProcDNA is a global rocket ship in life sciences consulting. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 400+ across 8 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. Ready to join our epic growth journey?

What we are looking for

We are seeking a Senior Engagement Lead - Technology to join our team. You are someone with a strong understanding of the pharmaceutical industry, in-depth knowledge of datasets like LAAD, DDD, XPO, and enjoy working with complex data sets to help clients solve real-world problems. You will play a key role in driving business performance, navigating risks, and developing pragmatic strategies through data-driven insights.

What you will do

• Lead Data Management Projects: Drive end-to-end data engineering and BI solution delivery for multiple clients, ensuring timely execution and adherence to project plans
• Data Integration & Visualization: Build integrated data solutions and visualizations using tools like Tableau/Power BI to support impactful business storytelling.
• Client Engagement & Solution Design: Collaborate with clients to understand business challenges and deliver customized analytics solutions with high-quality UX/UI design.
• Data Governance & Security Compliance: Ensure analytics solutions align with data governance, quality, and security frameworks.
• Cross-Functional Collaboration: Work closely with internal teams to align technical implementations with business goals and ensure seamless solution delivery.

Must Have

• Experience: 8–10 years in pharma technology consulting, with at least 6 years of U.S. project exposure and direct client interaction.
• Technical Expertise: Proficient with ETL tools (ADF, Databricks, Informatica), data workflow tools (Airflow, Azkaban), and storage systems (SQL/NoSQL, Snowflake, Redshift).
• BI Tools & Visualization: Strong hands-on experience in building dashboards and BI solutions using Tableau and Power BI.
• Data Strategy Knowledge: Solid understanding of data governance, quality frameworks, and experience designing enterprise data warehouse solutions.
• Communication & Problem-Solving: Excellent presentation, analytical thinking, and stakeholder management skills.

The AV Supervisor will oversee daily operational activities for the Autonomous Vehicle (AV) Drive Operations Program across designated city sites. This role ensures smooth field operations, compliance with safety standards, quality of service delivery, and team performance. The AV Supervisor will work closely with local and regional leaders to ensure efficient deployment of AV fleets and consistent driver/operator management.

Key Responsibilities

• Lead, coordinate, and supervise AV Driver/Operator teams across assigned locations.
• Conduct daily shift planning, scheduling, task delegation, and attendance tracking.
• Ensure compliance with all safety, security, and operational protocols.
• Train, coach, and mentor new and existing AV operators on operational procedures and program standards.
• Conduct performance reviews, provide feedback, and manage disciplinary actions when required.
• Collaborate with cross-functional teams (Operations, Fleet, Safety, Engineering) to ensure vehicle readiness and resolve operational issues.
• Monitor site productivity metrics and implement improvements to enhance efficiency.
• Respond to on-ground escalations and operational emergencies promptly.
• Prepare weekly operational status reports and performance summaries.
• Coordinate with Fleet & Maintenance teams to ensure optimal vehicle uptime.
• Travel between Tampa, Baltimore, and Pittsburgh as operational needs require.

Qualifications

• 3+ years of experience in Operations, Transportation, Logistics, Automotive, or related field.
• Prior experience in a supervisory or lead role managing teams.
• Strong understanding of safety protocols and compliance-driven environments.
• Excellent communication, leadership, and people management skills.
• Ability to analyze performance metrics and identify process improvement opportunities.
• Comfortable working in dynamic and fast-paced field settings.
• Valid driver's license with a clean driving record.
• Ability to travel between assigned cities as needed.

Preferred Skills

• Experience working with autonomous vehicles, fleet operations, or mobility transportation programs.
• Knowledge of incident reporting, compliance documentation, and operational audits.
• Technical aptitude to understand basic AV system operations and diagnostics

Work Environment

• Significant travel required - approximately 90% of the time across locations.

Job Title: Cloud Developer

Location: Boston, MA

Employment Type: Full-Time

Job Description

We are seeking an AWS-focused engineer to build and operate a cloud analytics and dashboard layer for device and fleet data. Data lands in S3 and is queried primarily through Amazon Athena. You will own the end-to-end delivery of reliable datasets, SQL queries, and visualization dashboards used by engineering and operations teams. This role requires strong execution in a fast-paced, ambiguous environment, with a high bar for quality, operational excellence, and written communication.

Responsibilities

• Own dashboard and analytics deliverables end-to-end (design → build → test → release → operate).
• Build and maintain Amazon Athena SQL queries, views, and datasets that support filtering, drill-down analysis, and repeatable reporting.
• Develop and enhance dashboards using QuickSight and/or CloudWatch dashboards (or equivalent AWS-native visualization tooling).
• Define metrics/KPIs with stakeholders and translate requirements into clear, actionable visualizations.
• Improve cost and performance of analytics workflows (partition strategies, query optimization, efficient formats, and operational guardrails).
• Drive data quality and correctness: detect schema changes, missing partitions, late data, and regressions; write RCAs and implement durable fixes.
• Implement mechanisms that scale (dashboards as mechanisms, SLIs/SLOs where applicable, alarms, runbooks, and automated checks).
• Collaborate cross-functionally with teams responsible for ingestion/ETL; contribute to ETL as a plus (Lambda, Step Functions, scheduling).

Essential Skills

• 4+ years of relevant experience delivering dashboards and analytics solutions in AWS.
• Strong SQL proficiency with experience building maintainable, production-grade query logic.
• Hands-on experience with Amazon Athena and S3-based analytics workflows.
• Experience with QuickSight and/or CloudWatch dashboards (or comparable visualization tools integrated with AWS).
• Proficiency in TypeScript (expected usage mix approximately 60% TypeScript / 40% other technologies).
• Strong SDLC discipline: Git, code reviews, automated testing, and CI/CD.
• Strong troubleshooting and root-cause analysis skills; ability to drive issues to closure.
• Strong written communication (design notes, operational runbooks, incident summaries).
• Experience with AWS CDK (TypeScript) and Infrastructure as Code practices.

Job Title: Cloud Developer

Job Description

We are seeking an AWS-focused engineer to build and operate a cloud analytics and dashboard layer for device and fleet data. Data lands in S3 and is queried primarily through Amazon Athena. You will own the end-to-end delivery of reliable datasets, SQL queries, and visualization dashboards used by engineering and operations teams. This role requires strong execution in a fast-paced, ambiguous environment, with a high bar for quality, operational excellence, and written communication.

Responsibilities

• Own dashboard and analytics deliverables end-to-end (design → build → test → release → operate).
• Build and maintain Amazon Athena SQL queries, views, and datasets that support filtering, drill-down analysis, and repeatable reporting.
• Develop and enhance dashboards using QuickSight and/or CloudWatch dashboards (or equivalent AWS-native visualization tooling).
• Define metrics/KPIs with stakeholders and translate requirements into clear, actionable visualizations.
• Improve cost and performance of analytics workflows (partition strategies, query optimization, efficient formats, and operational guardrails).
• Drive data quality and correctness: detect schema changes, missing partitions, late data, and regressions; write RCAs and implement durable fixes.
• Implement mechanisms that scale (dashboards as mechanisms, SLIs/SLOs where applicable, alarms, runbooks, and automated checks).
• Collaborate cross-functionally with teams responsible for ingestion/ETL; contribute to ETL as a plus (Lambda, Step Functions, scheduling).

Essential Skills

• 4+ years of relevant experience delivering dashboards and analytics solutions in AWS.
• Strong SQL proficiency with experience building maintainable, production-grade query logic.
• Hands-on experience with Amazon Athena and S3-based analytics workflows.
• Experience with QuickSight and/or CloudWatch dashboards (or comparable visualization tools integrated with AWS).
• Proficiency in TypeScript (expected usage mix approximately 60% TypeScript / 40% other technologies).
• Strong SDLC discipline: Git, code reviews, automated testing, and CI/CD.
• Strong troubleshooting and root-cause analysis skills; ability to drive issues to closure.
• Strong written communication (design notes, operational runbooks, incident summaries).
• Experience with AWS CDK (TypeScript) and Infrastructure as Code practices.

Additional Skills & Qualifications

• Experience building or supporting ETL pipelines using AWS Lambda, Step Functions, Glue, and/or EventBridge.
• Familiarity with IoT/telemetry data flows (device-to-cloud) and schema evolution patterns.
• Experience with observability (logs/metrics/alerts), operational excellence practices, and on-call readiness.

Work Environment

This role operates in a dynamic environment focusing on AWS technologies, including Amazon Athena, S3, QuickSight, CloudWatch, and AWS CDK. The position requires a high level of collaboration across teams, with a strong emphasis on quality and operational excellence. You will engage in cross-functional projects and contribute to the end-to-end analytics solutions within a fast-paced setting.

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.

About the Role

Join our dynamic R&D team as a Quality Control Inspector. In this role, you’ll play a critical role in ensuring that our Pulse IVL System product meets established quality standards and specifications at various points in the organization while advocating for strict adherence to compliance practices within the facility.

Key Responsibilities

• With minimal supervision, performs incoming, in-process, and final inspections of components and finished device.
• Interprets quality inspection documents and deciphers quality expectations for the product.
• Approves products by confirming specifications, conducting visual and measurement tests, returning products for re-work and confirming re-work
• Monitors use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately
• Performs and documents results of inspections per company procedures.
• Responsible for initiating non-conformance reports and ensuring non-conforming material is processed in accordance with the disposition. May assist with nonconformance investigations as needed.
• Review and verify documentation for compliance with specifications and regulatory requirements (e.g., FDA, ISO 13485).
• Maintain accurate inspection records and support traceability and documentation control.
• Collaborate with engineering and manufacturing teams to identify and resolve quality issues.
• Assist in root cause analysis and corrective/preventive actions (CAPA).
• Support internal audits and regulatory inspections.
• Ensure calibration and maintenance of inspection tools and equipment.

Required Qualifications

• Associate or bachelor’s degree in business, supply chain, life sciences or other scientific field or equivalent work experience (3-5 years).
• 3+ years of experience in quality inspection in the medical device industry.
• Strong understanding of quality systems and regulatory standards (ISO 13485, FDA 21 CFR Part 820).
• Proficiency in using inspection tools (calipers, micrometers, gauges, vision systems) and reading technical drawings/specifications.
• Excellent attention to detail and documentation skills.
• Ability to work independently and as part of a cross-functional team.
• Strong communication and problem-solving skills.
• Experience with electronic documentation systems (e.g., eQMS).
• Familiarity with cleanroom protocols and GMP practices.
• ASQ certification (e.g., CQI) is a plus.
• Two (2) or more years of laboratory experience
• Experience in QC inspection, cleanroom manufacturing, and medical device start-up
• 3+ year of Quality Control Experience in Medical Device Manufacturing. Knowledge of clean room operations
• Understanding of a quality management system (QMS) and cGMP knowledge
• Proficient level with Microsoft Office (Outlook, Excel, PowerPoint, and Word)
• Knowledge of Non-Conformance Reports (NCRs)

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:

The Quality Engineer I / II will support Quality Assurance activities for Vaxess’ combination product programs, with a strong focus on medical device design controls, risk management, and cGMP compliance. This role provides hands-on quality support across design and development, supplier oversight, process validation readiness, and batch record/data review, aligned with ISO 13485, 21 CFR 820, and applicable combination product regulations (21 CFR 4).

Reporting to the Quality Assurance Manager, this role works cross-functionally with Manufacturing, Process Development, Quality Control, and Material Management to support compliant execution and ensure product quality and safety during early clinical development.

Responsibilities:

• Support quality oversight of Vaxess combination product(s) to ensure compliance with safety, efficacy, and regulatory requirements.
• Administer and support the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, 21 CFR Part 4 (Combination Products), and applicable FDA and international regulations.
• Provide quality support for Design Control activities, including Design History File (DHF) maintenance, design reviews, Design Verification and Validation (DVV), and design changes.
• Support risk management activities, including development and maintenance of risk analyses (e.g., FMEA, hazard analyses) and linkage to design and process controls.
• Support process validation and qualification activities, including test method validation (TMV), process validation (PV), and equipment qualification, as applicable to Phase I and GMP-ready manufacturing.
• Participate in Material Review Board (MRB) activities, including nonconformance assessment, disposition, and documentation.
• Perform quality review and approval of batch records, executed manufacturing records, analytical data collection forms, test records, and technical or experimental reports.
• Collaborate in supplier quality management activities, including supplier qualification, auditing, monitoring, change evaluation, and periodic requalification.
• Author, review, and revise quality documentation, including SOPs, work instructions, test methods, protocols, reports, forms, and specifications.
• Support preparation, review, and organization of quality data and documentation for regulatory submissions and inspections.
• Contribute to continuous improvement initiatives within the QMS, including CAPA, deviation investigations, and quality metrics.

Qualifications:

• Quality Engineer I: Minimum of 3 years of experience in Quality Assurance or Quality Engineering within a cGMP-regulated medical device or combination product environment.
• Quality Engineer II: Typically 4–5 years of progressive quality experience in medical devices, pharmaceuticals, biologics, or combination products.
• Working knowledge of ISO 13485 and FDA medical device Quality System Regulations (21 CFR 820); familiarity with combination product requirements strongly preferred.
• Experience supporting early-phase (preclinical to Phase I) product development is highly desirable.
• Experience with design controls, risk management (FMEA), and validation activities preferred.
• Experience reviewing GMP documentation such as batch records, test methods, protocols, and reports.
• Strong written and verbal communication skills, with the ability to clearly document technical and quality concepts.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).

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: 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:

The Quality System Specialist / Senior Quality System Specialist plays a key role in supporting and enhancing Vaxess Technologies’ Quality Management System (QMS) to ensure compliance with applicable GMP/GLP standards. This position focuses on maintaining robust electronic quality systems, managing controlled documentation, and supporting the integration of new processes and applications.

Responsibilities:

Quality System and Computerized System Oversight

• Support quality oversight for computerized systems, including QMS implementation, configuration, validation, and data migration activities.
• Assist in launching new or enhanced system functionalities and communicating updates or user guidance to ensure effective adoption.
• Collaborate with internal stakeholders and system vendors to ensure integrated processes across modules (Document Control, Training, Equipment, and Material Management).
• Troubleshoot and resolve user issues as needed.

Documentation and Record Management

• Manage the full lifecycle of controlled documents, including creation, revision, review, approval, distribution, and archival within the electronic document management system (EDMS).
• Ensure that controlled documents, such as SOPs, batch records, and specifications, are accurate, current, and compliant with regulatory and internal requirements.
• Coordinate document workflows with cross-functional teams to ensure timely completion and alignment with procedural requirements.
• Author or revise SOPs, forms, and work instructions supporting quality system and GMP operations.

Training and Compliance Support

• Provide training and day-to-day support to employees on document control and system processes.
• Serve as a subject matter expert (SME) for document control and computerized systems during internal and external audits and inspections.
• Support tracking and reporting of quality metrics (e.g., training completion, document cycle time, CAPA effectiveness) to drive continual improvement.

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline preferred; equivalent work experience considered.
• 2–5 years of experience in a GMP, GLP, or GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry).
• Experience with electronic quality management systems (e.g., Enzyme, Greenlight Guru, Veeva, MasterControl, etc.) is strongly preferred.
• Familiarity with relevant regulations and standards (21 CFR Parts 210/211/11/820; ISO 9001/13485).
• Excellent attention to detail, organization, and communication skills; ability to manage multiple priorities in a dynamic environment.

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

Industry: Pharmaceuticals

Title: Quality Assurance Associate II

Job ID: CAMB000111

Location: Cambridge MA (Hybrid)

Duration: 12 months contract (+Possibility of extension)

Duties

• Review of event documentation such as Batch records, Exceptions, and Regulatory filings
• Production record review and Product disposition for drug substance, drug product, device assembly and finished goods
• Support design development plan including design verification and DHF deliverables
• Build and maintain Product Specification Files (PSF) for Clients program

Skills

• Knowledge of relevant government regulations and agency rules for labeling (CFR & EudraLex Volume 4, Annex 13)
• Understanding of ICH, GLP, CGMP requirements, GXP regulations and current industry practices.
• Demonstrated teamwork, initiative, and problem-solving skills
• Ability to prioritize and work independently with minimal supervision
• Ability to accurately determine deadlines and ask for help if needed
• Detail oriented with solid problem solving acumen.
• Ability to work effectively in a team environment with great organization skills.
• Ability to independently analyze and reconcile moderate to complex issues.
• Must have demonstrated initiative and accountability in a fast paced environment.
• Excellent verbal and written communication and interpersonal skills.
• Proficient with computers and word processing software (i.e., Microsoft Office products)

Education

• Minimum, a BS degree in life sciences, engineering or related field
• Minimum of 5 years pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment
• To have been involved on a device development project before as QA
• Signed off on design development plan, completed design verification, approved DHF deliverables
• Good understanding of FDA and EMA regulations and guidelines
• Excellent organizational, communication, and interpersonal skills.
• Preferred Quality Drug Substance manufacture experience