Engineering Jobs in Everett Middlesex County Ma Flexible

Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radio antibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development, and cancer biology, and Convergent’s proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radio antibodies precisely target cancer cells with potent, localized radiation.

In addition to the roles and responsibilities outlined below, we value team members who are eager to make an impact and grow with us professionally. We are seeking an individual who enjoys multi-tasking and has the willingness and flexibility to assume additional responsibilities as assigned.

Location: 50 Milk Street, Boston, MA

Reporting to: Caitlyn Harvey, SVP of Technical Operations

Responsibilities

• Create a strategy and lead the MSAT function through CPI, Phase 3 IND submission, PPQ and CPV (this includes API, Drug Substance, and Drug Product).
• Lead technology transfers and author technical documents including reports, standard operating procedures, master batch records, work instructions
• Collaborate with the Development Lead to learn and document the process as well as co-author development protocols and development technical reports.
• Responsible for authoring key IND updates and justifications
• Responsible for authoring MVP
• Provide onsite support at the CDMO, develop a training plan for manufacturing operators, and oversee process execution
• Lead investigations to troubleshoot process execution challenges including RCA
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

Requirements

• BS and/or MS in Chemical, Biological, or Biomedical Engineering
• 10+ yrs or equivalent combination of education and work experience
• Experience authoring IND sections
• Previous experience with antibody based drug substances and antibody-drug-conjugates
• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator.
• Working knowledge of statistical design of experiments (DoE) and RCA.
• Excellent technical writing skills
• Ability to travel up to 25% of the time
• This is a Hybrid role, in office 2 to 3 days a week
• We are considering Greater Boston based candidates only

Nice to haves:

• Knowledge of radiochemistry
• Understanding of analytical methods such as HPLC, SPR, and cell based assays.
• Experience developing scale down models

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.

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

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.

Title: Master Production Scheduler

Location: Greater Boston Area, MA (100% onsite)

Employment Type: Contract (6+ months)

Status: Accepting Candidates

About the role

Seeking a scheduling lead to serve as the site’s master production scheduling owner within a manufacturing environment. This role drives alignment across functional schedulers, leads governance forums, and owns scheduling metrics, systems accuracy, and dashboard visibility.

Key Responsibilities

• Serve as Master Production Scheduler, maintaining the site scheduling source of truth
• Lead recurring Scheduling Governance Forums, including agenda, facilitation, documentation, and follow-up
• Develop and own Scheduling KPIs (adherence, stability, execution performance)
• Track and analyze schedule performance trends and drivers of deviation
• Build and maintain Smartsheet workflows and dashboards for scheduling visibility
• Ensure disciplined use and accuracy of Scheduling Systems across function

Qualifications

• Bachelor’s degree in Operations, Supply Chain, Engineering, Business, or related field
• 5+ years of experience in Scheduling, Supply Chain, Manufacturing Operations, or Program Management
• Experience acting as a Central Scheduler, Systems Owner, or Planning Integrator
• Strong experience with Smartsheet
• Pharma experience preferred; manufacturing background required

Compensation (MA Pay Transparency):

• Estimated hourly range: $50–$65/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.

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