Sr. ASIC Design Engineer, Blink/Ring ASIC Team
Staff engineer job in North Reading, MA
Join the team which delivers highly differentiated silicon into Amazon Cameras and Doorbells. Our team works on state-of-the art SoCs in a vertically integrated team environment to deliver products our customers love. Drive early architectural and micro-architectural trade-offs to reduce time-to-revenue by shortening the time to revenue. Innovators will be delighted with our integrated verification/validation environment that is used to perform architectural modeling to post-silicon validation. The team works backwards from customer requirements to build super-low power, energy efficient designs that include the latest in AI, video processing, low power communications and CMOS fabrication technology.
Key job responsibilities
-Define architecture specifications based on requirements from product teams
-Create microarchitecture specifications suitable for being implemented by junior engineers
-Evaluate 3rd party IP blocks
-Estimate power, performance, and area for significant IPs early in design cycle
-Execute on design specifications to deliver high quality RTL
-Ensure quality by running and tracking results of front-end tools including: Synthesis, Lint (RTL, DFT, UPF), Power Analysis and STA
-Take the lead and work with verification teams to define functional coverage
-Work with pre-silicon verification teams to assist in defining testplans/testbenches
-Work with post-silicon validation teams to define and execute on testplans
-Write high quality documents to guide and lead a scalable team
BASIC QUALIFICATIONS-Bachelor's degree in Electrical Engineering, Communications Engineering or related field, or equivalent experience
-Experience with products that have gone to volume production
-Hands on experience in low power design techniques
-Strong written and verbal skills
PREFERRED QUALIFICATIONS-Master's or Ph.D degree in Electrical / Communications Engineering
-Exposure to Formal verification
-Experience with physical implementation flows
Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status.
Los Angeles County applicants: Job duties for this position include: work safely and cooperatively with other employees, supervisors, and staff; adhere to standards of excellence despite stressful conditions; communicate effectively and respectfully with employees, supervisors, and staff to ensure exceptional customer service; and follow all federal, state, and local laws and Company policies. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness and professionalism, and safeguard business operations and the Company's reputation. Pursuant to the Los Angeles County Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner.
Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $143,300/year in our lowest geographic market up to $247,600/year in our highest geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Amazon is a total compensation company. Dependent on the position offered, equity, sign-on payments, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits. For more information, please visit This position will remain posted until filled. Applicants should apply via our internal or external career site.
Mechanical Engineer Co-Op
Staff engineer job in Waltham, MA
Mechanical Engineer Co-Op (January-July 2026)
On-site in Waltham, Massachusetts
Amplitude Vascular Systems (AVS), an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease, is seeking a Mechanical Engineer-Co-Op to support our R&D team. This individual will work in a cross-functional role (Quality/Manufacturing/R&D) supporting the development of devices and associated instruments and technologies. This position offers a unique opportunity to experience the end-to-end process of product development. The Co-Op will work with senior level engineer(s) supporting product development activities to include the following:
Key Responsibilities:
Assist in the design and development of mechanical components and assemblies for medical devices.
Create and revise CAD models and engineering drawings using SolidWorks or similar software.
Support prototype fabrication, testing, and evaluation in collaboration with cross-functional teams.
Perform mechanical testing and data analysis to validate design concepts and product performance.
Document design iterations, test results, and engineering decisions in accordance with regulatory standards.
Participate in design reviews, brainstorming sessions, and risk assessments.
Collaborate with Quality, Regulatory, and Manufacturing teams to ensure design feasibility and compliance.
Qualifications
Enrolled in an accredited college, pursuing a Bachelor's or Master's Degree in Mechanical or Biomechanical Engineering (Junior year or above)
Self-motivated with an interest in medical devices
3-D modeling skills (SolidWorks)
Experience with machine design, 3D printing, GD&T, human factors (ergonomic design) and pneumatic/hydraulic systems preferred.
Experience using hand tools and performing mechanical testing
Experience with basic electronics work (Soldering, crimping, etc)
Proven problem-solving capabilities
Ability to communicate technical information
Previous co-op completed in R&D or manufacturing at a medical device demonstrating skillsets listed above preferred.
A minimum G.P.A. of 3.0
Available to work full-time (40 hrs/week) January - July 2026
This position is located onsite in Waltham, MA.
AVS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Mechanical Engineer
Staff engineer job in Woburn, MA
Our client in Woburn, MA is looking to bring on a Mechanical Engineer. Our client is looking for candidates who come from the medical device industry. The role is a direct hire with full benefits.
Responsibilities
As a Senior Mechanical Engineer, you will be responsible for the design, development, and implementation of mechanical systems and components for medical devices in compliance with regulatory standards.
Work with engineers across disciplines in the design and development of medical devices from concept to production.
Drive innovation and continuous improvement in system design processes and methodologies.
Collaborate closely with cross-functional teams including R&D, product management, quality assurance, and regulatory affairs to ensure successful product development.
Establish and maintain design control processes to ensure compliance with regulatory requirements such as FDA, CE, and ISO.
Provide technical guidance and mentorship to the peers, fostering a culture of excellence and accountability.
Participate in risk management activities and provide input on design mitigations to ensure product safety and efficacy.
Qualifications
Bachelor's degree in Mechanical Engineering; Master's degree preferred.
5+ years of experience in mechanical engineering, with 3+ years of experience in the medical device industry.
Proven track record of successfully leading and managing cross-functional engineering teams in the development of medical devices.
Strong understanding of mechanical design principles, materials selection, and manufacturing processes relevant to medical devices.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal teams and external partners.
Experience with solid modeling (SolidWorks), engineering drawings, GD&T, and design for manufacturability and assembly (DFMA).
Engineer I, Product Development
Staff engineer job in Woburn, MA
Vaxess is an NIH and venture-funded company developing a pipeline of next-generation vaccines on the MIMIX platform. With only five minutes of wear-time on the skin, the self-applied MIMIX patch enables weeks of sustained delivery in the skin. The platform combines high 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.
Device development at Vaxess is cross-disciplinary, integrating mechanical engineering, biomedical engineering, chemical engineering, biomaterials, chemistry, biology, and human factors to address important unmet medical needs.
The Engineer I will use technical skills in the development and testing of innovative products delivering vaccines. The individual will perform and support a variety of development and engineering activities, which mainly focus on disposable and re-usable devices prototyping, fabrication and testing. Will work directly with principal engineers to complete duties described below.
Responsibilities
Perform testing to support design, process, and equipment verification and validation.
Assist engineers with product and process development and improvement.
Prepare test samples for routine and qualification testing.
Support the build and assembly of prototypes.
Assist in troubleshooting of procedures and/or instruments when issues arise.
Maintain accurate documentation of concepts, designs, and test reports.
Assist in engineering and clinical builds in support of clinical studies and commercialization.
Other duties as assigned.
Qualifications
BS Mechanical Engineering or BS Biomedical Engineering plus 0-2 years' medical device experience.
Experience with test method development and execution is a plus.
Familiar with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and laboratory practices.
Ability to work in a fast-paced environment while managing multiple priorities.
Proven time management skills and ability to achieve goals within timelines.
Comfortable working in a clean room environment.
Ability to communicate effectively.
Experience with MS Office.
Employee may be required to lift objects up to 25lbs.
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.
Vaxess aims to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.
If you're interested in joining the Vaxess team, please submit your CV/resume to
******************
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Mechanical Engineer
Staff engineer job in Andover, MA
Job Title: Mechanical Engineer
Digital Health Solutions (DHS) is a premier consulting firm dedicated to helping medical device companies navigate complex regulatory, engineering, and product development challenges. We specialize in guiding clients through IEC 62304 and ISO 13485 compliance, supporting them in delivering innovative, safe, and effective medical technologies to market.
Position Overview
We are seeking a Mechanical Engineer with 2 years of industry experience in product design, prototyping, or testing. This is a highly hands-on role that offers exposure to a wide range of engineering activities including mechanical design, fabrication, prototyping, electro-mechanical testing, and manufacturing support.
You will have the opportunity to work on a diverse range of medical technologies, including handheld diagnostic devices, point-of-care testing systems, wearable health monitors, and remote patient monitoring platforms. Projects often integrate mechanical, electrical, firmware, and software systems offering broad exposure to the full product lifecycle from early concept to production.
The ideal candidate thrives on variety, enjoys solving open-ended technical problems, and works comfortably both independently and in collaborative, cross-functional teams.
Key Responsibilities
Design and model components and assemblies using SolidWorks CAD software.
Build and test prototypes using in-house tools and fabrication techniques (e.g., 3D printing, hand-tools, assembly).
Plan and perform mechanical and electrical tests, collect data, and prepare detailed technical reports.
Support product development across mechanical, electrical, and system-level disciplines.
Contribute to manufacturing readiness, including DFM/DFA review and supplier coordination.
Participate in design reviews, verification and validation efforts, and continuous improvement initiatives.
Collaborate closely with senior engineers to translate concepts into manufacturable designs.
Preferred Qualifications
Bachelor's or Master's degree in Mechanical Engineering or related field.
2+ years of hands-on engineering experience in product design, R&D, or manufacturing.
Interest in medical device development and regulatory processes
Proficiency in SolidWorks (part and assembly modeling, drawings, and tolerancing).
Strong hands-on skills with prototyping tools, fixtures, and instrumentation.
Familiarity with mechanical testing, data acquisition, or basic electronics.
Excellent problem-solving, communication, and documentation skills.
Detail-oriented with a strong sense of ownership and initiative.
Bonus: Experience with electrical design, PCBA integration, sensors, automation, embedded systems, or mechatronic integration.
Bonus Qualifications:
Experience with IEC 60601 standards or other medical device regulatory frameworks.
Knowledge of Quality Systems (ISO 13485, FDA QSR) and related documentation practices.
Proficiency in GD&T (Geometric Dimensioning and Tolerancing) for precise mechanical design and inspection.
Exposure to sensors, automation, or embedded hardware integration
What You'll Gain
· Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.
Mentorship from industry experts in engineering, regulatory affairs, and quality systems
Exposure to all stages of the product lifecycle from concept through production.
Practical experience with FDA regulations, ISO standards, and product development lifecycles
A collaborative and fast-paced environment where innovation and creativity are valued.
Principal Specialist Engineering Services
Staff engineer job in Lawrence, MA
Country:
United States of America Onsite
U.S. Citizen, U.S. Person, or Immigration Status Requirements:
Active and transferable U.S. government issued security clearance is required prior to start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance
Security Clearance:
DoD Clearance: Secret
At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today's mission and stay ahead of tomorrow's threat. Our team solves tough, meaningful problems that create a safer, more secure world.
Life Cycle Engineering (LCE) is responsible for ensuring our products are Safe, Reliable, Maintainable and delivered on time. Life Cycle Engineering consists of multiple disciplines that support engineering, our program offices and our customers. Our Life Cycle Engineering disciplines participate in the total life cycle of our products from conception to deactivation. Our focus area is product support, including the following disciplines: Reliability System Safety and Supportability.
What You Will Do:
As a Senior Engineering Logistics Specialist, you'll be the Project Lead supporting repair contracts for both ground and missile systems to ensure repaired assets are returned to the customer in accordance with the financial and schedule limitations of the contract.
In this role you'll execute in a highly dynamic environment as each repair needs to be individually tracked. You'll coordinate and collaborate with the repair performing locations and across functional areas like supply chain and finance to provide the current status of the repairs to program management and the customer.
Additional responsibilities may include:
Perform budget and schedule analysis for all repairs.
Coordinate with supporting functions to move repair assets through the process.
Consolidate and present weekly status of repairs, manage monthly contract deliverables.
Prepare and present metrics and status at internal and external program reviews
This job can be based in either Massachusetts, El Paso, TX, Huntsville, AL.
This role is posted as Onsite. Commuting costs to and from the named Raytheon facility are the responsibility of the incumbent.
Qualifications You Must Have:
Typically Requires: Bachelor's Degree and a minimum 5 years of relevant material acquisition, supply chain, logistics, operations, manufacturing, depot operations, engineering or maintenance experience. An advanced degree may account for additional years of experience as required for this position.
Experience in program planning, budgeting, and tracking (EVMS) to cost and schedule
Experience with logistics support, Repair& return processes, or manufacturing.
Active and transferable U.S. government issued security clearance is required prior to start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance.
Qualifications We Prefer:
Patriot System product knowledge and or experience
Detail orientated and demonstrated ability to effectively work in a team Knowledge, understanding of FMS and DCS contract execution.
Knowledge, understanding and application of PRISM, SAP, ARMS, APEX
Self-initiative, strong written and oral communication skills
Experience presenting data to audiences of varying sizes
Proficiency with Microsoft Office products
What We Offer
Our values drive our actions, behaviors, and performance with a vision for a safer, more connected world. At RTX we value: Trust, Respect, Accountability, Collaboration, and Innovation.
Learn More & Apply Now!
The salary range for this role is 82,000 USD - 164,000 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window.
RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act.
Privacy Policy and Terms:
Click on this link to read the Policy and Terms
Principal R&D Electronic Engineer
Staff engineer job in Newton, MA
The Principal Electronics Engineer will be a part of the R&D organization and an important contributor to the realization of the next generation robotic platform that will change the future of healthcare.
You will be a technical lead in driving to resolve complex multi-disciplinary issues. Additionally, you will create, refine and implement technical processes and best practices for electrical engineering development. The result of your work will directly influence design iterations in a regulated medical device development environment.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Principal Electrical Engineer, Robotics, you will be responsible for:
Responsible for leading multidisciplinary teams to debug and troubleshoot complex issues and to thoroughly document the investigation including recommendations to design
Responsible for electrical engineering planning and design for robustness and reliability for PCBs and cabling
Responsible for generating and implementing best practices and process documentation for electronics development
Project Management responsibilities may include vendor and supplier management, directing design and test technician resources.
May lead/conduct characterization or testing of PCBAs
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
You have technical systems understanding and interactions between electronics, controls/software and electromechanical disciplines
You have a solid understanding of determining system performance between cross disciplines
You have demonstrated successes in systematically determining root cause of electro-mechanical systems
You have strong electronics fundamentals for analog, digital and electromechanical design
You have strong presentation skills
You have strong technical collaboration skills including scheduling meetings/discussions, identifying discussion points and driving to obtain agreement on decisions for workstreams
You have experience developing Class II & III medical devices in a regulatory environment, applying relevant standards such as ISO 13485 IEC 60601-1, 60601-1-2
You have demonstrated experience with electronic design for motor control and mixed-signal electronic design for precise sensing applications
You are highly proficient in the use of electrical CAD tools, Altium preferred
You possess working knowledge of EMC and electrical safety
You have exceptional analytical skills with proficiency in analytical tools such as MATLAB/Simulink and Spice required
You have exceptional data analysis skills; required
You have excellent communication, teamwork, interpersonal skills with the ability to self-direct and have some project management skills
Required skills to have for the success of this role
Bachelor's degree in Electrical Engineering required, MS or PhD preferred
Minimum of 15 years of experience in R&D or product development required
Willing to travel up to 10%
Sustaining Manufacturing Engineer
Staff engineer job in Bedford, MA
Responsibilities:
Provides support to the Manufacturing organization to facilitate efficient operations within the production area to ensure that production goals are met.
Troubleshoot current design and process challenges, determine root cause, and implement robust solutions.
Support the Improvement of manufacturing procedures, inspections and test equipment necessary to improve the capabilities manufacturing.
Implement process documentation changes and train direct labor personnel.
Author and execute test protocols to validate manufacturing processes and equipment.
Use Lean manufacturing methods and identify improvements to reduce costs, increase yields, and ensure product quality.
Collaborate with contract manufacturing sites to improve product quality and achieve company goals.
Assist in maintaining systems for regulatory compliance.
Design, install and troubleshoot manufacturing equipment.
Monitor performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
Work with cross-functional groups including Product Development and Quality Engineering to analyze and disposition non-conforming products.
Implement process and design changes to improve ergonomic issues as well as integrating products into Lean Manufacturing.
Requirements:
Strong communication and interpersonal skills.
Bachelor of Science Degree in mechanical, electrical, or manufacturing engineering.
Minimum of 1-3 years' experience in medical device manufacturing
Experience supporting manufacturing process development, validations and qualifications
Proficient understanding of analog/digital electronics.
Proficiency with a variety of test equipment to include digital meters and power supplies.
Proficiency with Microsoft Office applications and Solidworks
Ability to interact with client companies (customer focused) and co-workers in a professional manner.
Willingness to support other functions as needed, in areas such as quality and design.
Willingness to travel to vendors and customer sites as needed (10% travel)
Preferred:
Knowledge of QSR and ISO 13485 requirements for Medical Devices.
Experience with Minitab, Statgraphics, Matlab, or Python
Knowledge of Lean methods
Principal Systems Engineer
Staff engineer job in Andover, MA
Title: Principal Systems Engineer
Industry: Medical Device company
FULLTIME
Responsibilities
Serve as the primary technical bridge between sensor technology partners and internal multidisciplinary teams
Offer expert-level input on system architecture decisions and evaluate design trade-offs
Own the technical roadmap and integration of biosensors and subsystems across the product portfolio
Oversee collaborations with external engineering and design vendors, monitoring progress against requirements, schedules, and quality benchmarks
Convert clinical and functional needs into system architectures and clearly defined, testable specifications
Drive design reviews, risk analyses, and integration strategies across electrical, mechanical, biochemical, software, and fluidic domains
Direct verification and validation efforts to confirm subsystem performance and overall system interoperability
Maintain alignment with relevant regulatory frameworks and standards, including ISO 13485, IEC 60601, and FDA expectations
Partner with internal R&D, clinical, regulatory, and software groups to achieve development milestones
Contribute to additional organizational responsibilities and assignments as needed
Senior AI Engineer - no visas please - 10 plus years exp
Staff engineer job in Boston, MA
Please contact Renu Goel ************ ***************** No visas please No corps 10 plus years exp Senior Member of Technical Staff (LMTS) - AI & Data Engineering This position requires expertise in designing, developing, debugging, and maintaining AI-powered applications and data engineering workflows for both local and cloud environments. The role involves working on large-scale projects, optimizing AI/ML pipelines, and ensuring scalable data infrastructure.
As a LMTS, you will be responsible for building Generative AI (GenAI) capabilities, building data pipelines for AI model training, and deploying scalable AI-powered microservices. You will collaborate with other AI/ML, Data Engineering, DevOps, and Product teams to deliver impactful solutions that enhance our products and services.
Preferred qualifications include experience with retrieval-augmented generation (RAG), fine-tuning pre-trained LLMs, AI model evaluation, data pipeline automation, and optimizing cloud-based AI deployments.
Responsibilities
AI-Powered Software Development & API Integration
• Develop AI-driven applications, microservices, and automation. Build and maintain Python based AI services using lang Chain and CrewAI.
• Integrate and optimize OpenAI APIs (GPT models, Embeddings, Function Calling), hugging Face, LangChain, and implement Retrieval-Augmented Generation (RAG) techniques to enhance AI-powered document retrieval and classification, agentic AI workflows
• Deploy AI-powered applications using AWS Lambda, Kubernetes, Docker, CI/CD pipelines
Data Engineering & AI Model Performance Optimization
• Experience with building and optimizing scalable data pipelines for AI/ML workflows using Pandas, PySpark, and Dask, integrating data sources such as Kafka, AWS S3, Azure Data Lake, and Snowflake.
• Experience in assessing AI models using model scoring, fine tuning embeddings and enhance similarity search for retrieval augmented applications
• Experience on enhancing AI model inference efficiency by implementing vector retrieval using FAISS, Pinecone, or ChromaDB, and optimize API latency with tuning techniques (temperature, top-k sampling, max tokens settings).
Microservices, APIs & Security
• Design and develop scalable RESTful APIs for AI models and data services, ensuring integration with internal and external systems while securing API endpoints using OAuth, JWT authetication, and API rate limiting.
• Implement AI-powered logging, observability, and monitoring to track data pipelines, model drift, and inference accuracy, ensuring compliance with AI governance and security best practices.
AI & Data Engineering Collaboration
• Work with AI/ML, Data Engineering, and DevOps teams to optimize AI model deployments, data pipelines, and real-time/batch processing for AI-driven solutions.
• Engage in Agile ceremonies, backlog refinement, estimate task accurately, drive incremental release of AI features, brainstorm different technical approaches to provide solutions in areas like fraud detection, claims processing, and intelligent automation.
Cross-Functional Coordination and Communication
• Work collaboratively across Technology, Product, AI/ML, and DevOps teams to align AI-driven enhancements with business goals.
• Build strong relationships with AI engineers, data scientists, and cloud architects to optimize LLM-based applications.
• Ensure AI compliance with security, ethical AI policies, and privacy standards (HIPAA, GDPR, SOC2, AI governance best practices).
Education & Experience Required
• 8 years of experience in software engineering or AI/ML development, preferably in AI-driven solutions.
• Hands-on experience with Agile development, SDLC, CI/CD pipelines, and AI model deployment lifecycles.
• Bachelor's Degree or equivalent in Computer Science, Engineering, Data Science, or a related field.
• Proficiency in full-stack development with expertise in Python (preferred for AI)
• Experience with structured & unstructured data: SQL, NoSQL, Big Data, Vector Databases and AI data pipelines
• Familiarity with Cloud & AI Infrastructure such as AWS, Azure, Kubernetes, Docker, CI/CD
• Experience with GenAI Frameworks & Tools: OpenAI API, Hugging Face Transformers, TensorFlow, LangChain, LlamaIndex, CrewAI.
• Experience in LLM deployment, retrieval-augmented generation (RAG), and AI search optimization.
• Experience in AI model evaluation (BLEU, ROUGE, BERT Score, cosine similarity) and responsible AI deployment.
• Strong problem-solving skills, AI ethics awareness, and the ability to collaborate across AI, DevOps, and data engineering teams.
• Curiosity and eagerness to explore new AI models, tools, and best practices for scalable GenAI adoption.
Estimated Min Rate: $115500.00
Estimated Max Rate: $165000.00
What's In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
Health Savings Account (HSA) (for employees working 20+ hours per week)
Life & Disability Insurance (for employees working 20+ hours per week)
MetLife Voluntary Benefits
Employee Assistance Program (EAP)
401K Retirement Savings Plan
Direct Deposit & weekly epayroll
Referral Bonus Programs
Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit ************************************************ to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh's hiring clients' preferences. To learn more about Yoh's privacy practices, please see our Candidate Privacy Notice: **********************************
Electrical Engineer
Staff engineer job in Worcester, MA
Electrical Design Engineer - Advanced Systems & Board Development
Lead end-to-end electronic design projects in a collaborative, high-performance engineering environment.
This role involves full lifecycle ownership of schematic capture, PCB design, system integration, and debugging. You'll work cross-functionally to deliver production-ready electronic systems while supporting existing platforms and driving continuous improvement.
Key Responsibilities:
Design and develop circuit boards using OrCAD or similar tools
Support FPGA integration and existing product enhancements
Create specifications, documentation, and test plans
Assist with manufacturing calibration and system debugging
Contribute to compliance and certification processes
Qualifications:
BS/MS in Electrical Engineering or related discipline
2-5 years of circuit or board design experience
Strong technical documentation and communication skills
Experience in one or more of the following is a plus:
Analog design
Control systems
Digital signal processing
Switching power supplies
✅ Interested in designing next-generation electronic systems?
Apply here to learn more or explore the opportunity!
Manufacturing Engineer
Staff engineer job in Ipswich, MA
🏭 Manufacturing Engineer
📍
Full-Time | On-Site | Ipswich, MA
U.S. Citizenship Required | Direct Hire
Are you a hands-on problem-solver who thrives on turning challenges into high-performance solutions?
Join our team as a Manufacturing Engineer, where you'll improve and reinvent how we build industrial-grade, metal-based products using cutting-edge CNC machinery and manufacturing technologies.
I
n this role, you'll go beyond tweaking processes-you'll lead transformative changes that boost efficiency, reduce costs, and elevate product quality across machining, welding, assembly, and testing operations.
🔧 What You'll Do:
Streamline production using lean manufacturing tools: time studies, value stream mapping, standard work, etc.
Identify and execute cost reduction opportunities via smarter designs, tooling, and automation.
Design and optimize facility layouts and workflows for greater throughput and safety.
Lead cross-functional initiatives in collaboration with engineering, quality, and production teams.
Drive adoption of new manufacturing technologies, CNC equipment, and automated solutions.
Create and maintain routings, labor standards, and production documentation in the ERP system.
Develop and implement standard work instructions and training documentation.
Support New Product Introductions (NPI) by developing tooling, methods, and process validation.
Run Kaizen and continuous improvement events focusing on SQDC (Safety, Quality, Delivery, Cost).
Utilize MES, ERP, and SPC systems to track key metrics, analyze performance, and inform data-driven decisions.
Mentor operators and shop floor teams on best practices and lean principles.
🧠 What You Bring:
Education:
Bachelor's Degree in Manufacturing, Mechanical, or Industrial Engineering
Experience:
3-5 years of experience in a discrete manufacturing environment
Familiarity with CNC machining, metal fabrication, or heavy industrial equipment is preferred
Preferred Certifications & Skills:
Lean Six Sigma (Green Belt or higher)
OSHA 10/30 or similar EHS training
Project Management certification (PMP or equivalent)
CAD proficiency (SolidWorks, AutoCAD)
ERP system experience (SAP, Oracle, or similar)
Familiarity with simulation/modeling tools
Strong analytical, project planning, and communication skills
Able to juggle priorities and meet deadlines in a fast-paced, high-mix environment
🚀 Why Join Us?
Be a change agent in a high-mix, engineered-to-order environment
Work on mission-critical solutions in structural, heavy industrial, and custom metal products
Join a team that values collaboration, creativity, and continuous learning
Make a visible impact on processes, cost, and quality from day one
Grow professionally with mentorship, challenging projects, and advancement opportunities
⚖️ Equal Opportunity Statement
We are an equal opportunity employer and value diversity in our workforce. We do not discriminate based on race, religion, gender, gender identity, sexual orientation, age, disability, or veteran status.
Robotics Engineer - Software and Integrations
Staff engineer job in Plymouth, MA
Greensea IQ is a world leader in advanced robotic solutions for the ocean. We area dual- use technology company that has pioneered the use of autonomous systems in critical defense applications and is now transitioning that mature technology to the commercial maritime markets.
Greensea has a defense product portfolio focused in Mine Countermeasures, Explosive Ordnance Disposal, and Special Operations. Since2017, we have pioneered the use of autonomous robots and artificial intelligence to create scale and safety in ocean warfare while protecting the warfighter.
Greensea's emerging Ever Clean product transitions defense technology to the commercial sector to create high impact and achieve significant growth within a large market. EverClean uses autonomous underwater robots to keep the hulls of ships clean, allowing ships to perform optimally. This Robot-As-A-Service business provides significant fuel savings, carbon missions reductions, and increased vessel performance through a simple subscription program.
Job Description
The Robotics Engineer - Software & Integrations will be a critical member of Greensea IQ's multidisciplinary engineering team, with primary responsibility for the Bayonet Family of Products at our Plymouth, MA facility. This role focuses on developing, maintaining, and integrating software into the Bayonet AUGV line of vehicles, RNAV family of systems, HANC Subsea Control System, and IQNS, ensuring production-ready deployment and robust system performance.
The engineer will lead the integration and testing of navigation, control, and embedded software systems on Bayonet products. They will collaborate closely with production technicians, software teams, and product managers, spending significant time in the field running and validating Bayonet systems.
Responsibilities
Serve as the principal stakeholder for the integration of software on the Bayonet line of products in Plymouth, MA location
Participate as a multidisciplinary engineering team member.
Work closely with other software stakeholders, including the software Product Manager and software development team for Greensea's defense software products, to land software successfully and reliably on the Bayonet production systems.
Support production technicians in the production and commissioning of Bayonet Family systems.
Design, analyze, develop, test, and integrate control and navigation software systems for unmanned vehicles and products.
Develop, test, and integrate device interface software drivers.
Support hardware integrations as a software application for robot systems.
Support robot testing as a software stakeholder.
Innovate to discover solutions that enhance the relationship between marine vehicles and the operators that use them.
Support clients and operators as they apply Greensea IQ's technology to the work they do in the field.
Produce clear, reliable, and reusable code.
Maintain clear documentation.
Actively and passionately participate in field testing.
All other responsibilities as reasonably assigned.
Requirements
Bachelor's degree in Math, Physics, Computer Science, or a related field.
3-5 years of relevant experience.
Proficiency in C++ or comparable object-oriented programming language.
Working knowledge of mobile or underwater robot systems, including their sensors, construction, and use.
Experience with hardware interfaces, embedded systems, edge processing, and distributed computing.
Strong working knowledge of the Linux operating system, embedded systems, and embedded Linux.
Strong written and oral communication skills.
To apply, please send your resume, salary requirements, and cover letter to careers@greensea IQ.com as PDF documents. The candidate must be eligible to work in the United States. This role may require occasional travel. This position is based in Plymouth, MA. Annual salary range: $115 - 130k.
Greensea IQ (************ IQ.com) is an equal opportunity employer. We offer a casual and fun work environment and provide our employees training and continuing education opportunities. GreenseaIQ offers competitive salaries and a complete benefits package, including full health insurance, 401(k), and paid vacation, holiday, and sick leave.
ASIC Verification Engineer, Blink/Ring ASIC Team
Staff engineer job in North Reading, MA
Join the team which delivers highly differentiated silicon into Blink and Ring battery powered devices. Our verification team works on state-of-the art SoCs in a vertically integrated team environment to deliver products our customers love. Our verification team is involved in early architectural and micro-architectural trade-offs to reduce time-to-revenue by shortening the DV cycle. Innovators will be delighted with our integrated verification/validation environment that is used to perform architectural modeling to post-silicon validation. The team works backwards from customer requirements to build super-low power, energy efficient designs that include the latest in AI, video processing, low power communications and CMOS fabrication technology.
Key job responsibilities
- Use and/or build bit accurate C models
- Evaluate block and sub-systems for testability/verifiability
- Write comprehensive block and system level testplans
- Build assertions, traffic generators and scoreboards
- Execute testplans and perform rigorous debug
BASIC QUALIFICATIONS- Bachelor's degree in Electrical / Computer Engineering or related field
- 5+ years experience in digital verification, preferably in image processor, SoC/Interfaces
- 3+ years of experience in C/C++ and scripting (Python or TCL)
- 5+ years experience in System Verilog or UVM
PREFERRED QUALIFICATIONS- Master's or PH.D in Computer Engineering
- 7+ years of experience in digital verificaiton, preferably in areas of image processing.
- Familiarity with Matlab
- Familiarity with formal verification techniques
- Lab debug experience and/or FPGA debug
- Strong written and verbal skills
Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status.
Los Angeles County applicants: Job duties for this position include: work safely and cooperatively with other employees, supervisors, and staff; adhere to standards of excellence despite stressful conditions; communicate effectively and respectfully with employees, supervisors, and staff to ensure exceptional customer service; and follow all federal, state, and local laws and Company policies. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness and professionalism, and safeguard business operations and the Company's reputation. Pursuant to the Los Angeles County Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner.
Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $129,800/year in our lowest geographic market up to $212,800/year in our highest geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Amazon is a total compensation company. Dependent on the position offered, equity, sign-on payments, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits. For more information, please visit This position will remain posted until filled. Applicants should apply via our internal or external career site.
Electro Mechanical Engineer
Staff engineer job in Woburn, MA
Our client in Woburn, MA is looking to bring on an Electro-Mechanical Engineer. This is a direct hire opportunity with a hybrid work schedule.
Responsibilities:
The Electro-mechanical Manufacturing Engineer is responsible for evaluating and refining current manufacturing processes and working with our Contract Manufacturers to establish best practices.
The Electro-Mechanical Manufacturing Engineer will be involved in the continued refinement of our production process to ensure that products can be manufactured to specifications. The position may be required to perform all, or a combination of the following essential responsibilities as determined by necessity.
Develop and implement manufacturing processes to ensure products are manufactured to the required specifications and standards. This includes creating work instructions, assembly procedures, and fixturing for the manufacturing process.
Work within the Engineering team to drive design for manufacturing and assembly early in the design process for new product development.
Evaluate and troubleshoot electromechanical systems including boards, communications, mechanical, simple vacuum system and handpieces issues.
Manage the manufacturing process to ensure that the products are manufactured to the required specifications and timelines. This includes monitoring the manufacturing process, identifying and resolving issues, and ensuring that the products meet the required quality standards.
Experience:
Bachelor's degree in Manufacturing Engineering, Mechanical or Electrical Engineering, or Industrial Engineering or equivalent job experience
5+ years of related engineering experience, preferably in new product development environment. Medical device experience desired.
Proficiency designing and developing manufacturing processes, work instructions, and test fixtures.
Familiarity with Lean Manufacturing and/or Six-Sigma Principles.
Familiarity with SPC and Statistical Sampling techniques.
Range: $130-140K+Bonus
Principal Specialist Engineering Services
Staff engineer job in Lowell, MA
Country:
United States of America Onsite
U.S. Citizen, U.S. Person, or Immigration Status Requirements:
The ability to obtain and maintain a U.S. government issued security clearance is required. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance
Security Clearance:
DoD Clearance: Secret
As a Principal Specialist, you'll be the Project Lead supporting repair contracts for both ground and missile systems to ensure repaired assets are returned to the customer in accordance with the financial and schedule limitations of the contract.
In this role you'll execute in a highly dynamic environment as each repair needs to be individually tracked. You'll coordinate and collaborate with the repair performing locations and across functional areas like supply chain and finance to provide the current status of the repairs to program management and the customer.
Work Location: Tewksbury, MA
Additional responsibilities may include:
Perform budget and schedule analysis for all repairs.
Coordinate with supporting functions to move repair assets through the process.
Consolidate and present weekly status of repairs, manage monthly contract deliverables.
Prepare and present metrics and status at internal and external program reviews
Qualifications You Must Have:
Typically Requires: Bachelor's Degree and a minimum 5 years of relevant material acquisition, supply chain, logistics, operations, manufacturing, depot operations, engineering or maintenance experience. An advanced degree may account for additional years of experience as required for this position.
Experience in program planning, budgeting, and tracking (EVMS) to cost and schedule
Experience with logistics support, Repair & Return processes, or manufacturing.
The ability to obtain and maintain a US security clearance. US citizenship is required as only US citizens are eligible for a security clearance.
Qualifications We Prefer:
Patriot System product knowledge and or experience
Detail orientated and demonstrated ability to effectively work in a team Knowledge, understanding of FMS and DCS contract execution.
Knowledge, understanding and application of PRISM, SAP, ARMS, APEX
Self-initiative, strong written and oral communication skills
Experience presenting data to audiences of varying sizes
Proficiency with Microsoft Office products
What We Offer
Our values drive our actions, behaviors, and performance with a vision for a safer, more connected world. At RTX we value: Safety, Trust, Respect, Accountability, Collaboration, and Innovation.
Learn More & Apply Now!
Please consider the following role type definition as you apply for this role
Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products.
The salary range for this role is 82,000 USD - 164,000 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window.
RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act.
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Engineer III, Platform Research
Staff engineer job in Woburn, MA
Vaxess is developing next generation medicines on our novel microneedle array patch (MAP) platform. The platform combines high temperature stability with simple self-application and only a five-minute wear time to dramatically alter the way that drugs are delivered. We are 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 science and engineering across biology, chemistry, materials, and mechanics to address important unmet medical needs in biologics delivery. We are seeking a talented, collaborative, and highly motivated individual with a background in process development, formulation, and analytical method development to join our core team of scientists and engineers. This is a unique opportunity to be part of an emerging startup bringing innovative technology to the global market.
Responsibilities
Serve as subject matter expert and lead on MAP manufacturing 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.
Provide technical guidance to and mentor/supervise junior engineers as needed.
Contribute to intellectual property filings and regulatory submissions.
Qualifications
BS or MS in Biomedical, Chemical, or Mechanical Engineering, or related discipline with at least 5 years of relevant R&D biotech or medical device experience.
Prior industry experience with novel platform and process/formulation development is preferred.
Experience formulating and characterizing proteins or peptides is a plus.
Familiarity with imaging and physical characterization techniques 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.
Vaxess, a venture-backed biotech company, is building a team of exceptional people to rapidly advance products on its microneedle array patch platform. 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 ******************.
Principal Systems Engineer
Staff engineer job in Andover, MA
Digital Health Solutions (DHS) is a premier consulting firm dedicated to advancing medical device innovation. We partner with companies across the medical technology spectrum to deliver safe, effective, and compliant solutions. With deep expertise in IEC 62304, ISO 13485, and FDA/EU regulatory frameworks, DHS helps clients accelerate product development while ensuring patient safety and clinical impact remain at the core. Our mission is simple yet powerful: to guide the development of medical technologies that improve and save lives.
Position Overview
We are seeking an accomplished Principal Systems Engineer to join our growing team. This role is ideal for a highly experienced systems thinker who thrives at the intersection of engineering, clinical application, and regulatory compliance. The Principal Systems Engineer will lead complex projects across Class II and III medical devices, bringing together cross-functional teams to deliver innovative solutions in areas such as neurostimulation, cardiac support, and medical imaging.
At DHS, you won't just contribute technical, you will shape strategy, mentor emerging engineers, and influence the next generation of patient-focused technology. This is a hands-on leadership role where you'll translate clinical needs into actionable requirements, architect and validate systems, and drive design control excellence from concept through commercialization.
We are looking for a candidate who combines technical depth, regulatory fluency, and leadership presence. The ideal candidate is someone who can balance innovation with compliance, build consensus across diverse stakeholders, and drive projects to successful completion in fast-paced environments.
Key Responsibilities
Lead systems engineering activities across the full product lifecycle, from concept through verification, validation, and commercialization.
Translate user and clinical needs into system, subsystem, and component requirements while maintaining rigorous traceability.
Participate in hardware and software design and development activities, working with engineers to ensure the design will meet requirements.
Ensure requirements can be verified in compliance with design controls and other QMS SOPs.
Architect system-level solutions, define interfaces, and guide trade-off analyses to achieve optimal design outcomes.
Oversee risk management activities (HA, FMEA, risk-benefit analysis) ensuring compliance with ISO 14971 and related standards.
Direct verification and validation strategies, author test protocols/reports, and coordinate testing with external labs.
Drive design control documentation and ensure adherence to ISO 13485, IEC 60601, IEC 62304, and FDA/EU regulations.
Collaborate cross-functionally with clinical, quality, regulatory, and manufacturing teams to resolve conflicts and ensure alignment.
Mentor junior engineers, fostering professional growth and building DHS's technical leadership bench.
Contribute to program management activities including project planning, deliverable tracking, and executive reporting.
Support business development efforts through technical input to proposals, client engagement, and thought leadership.
Preferred Qualifications
Master's degree in Biomedical, Electrical, Systems, or related Engineering field (PhD a plus).
10+ years of experience in systems engineering within Class II/III medical devices.
Proven track record in requirements management, system architecture, and verification/validation.
Strong knowledge of regulatory compliance (FDA 21 CFR Part 11/820, EU MDR, ISO 13485, IEC 60601, IEC 62304, ISO 14971).
Experience leading cross-functional teams, managing CAPAs, and closing complex regulatory gaps.
Skilled in tools such as JIRA, Confluence, and test management platforms.
Strong interpersonal skills with the ability to communicate effectively across technical and non-technical audiences.
What We Offer
Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.
The opportunity to work on cutting-edge medical technologies that directly improve patient lives.
Exposure to a broad range of projects and modalities, from implantable devices to advanced imaging systems.
Mentorship and collaboration with leading experts in systems engineering, regulatory affairs, and product development.
A role where your technical leadership and strategic insight shape both client success and DHS's growth.
The satisfaction of delivering solutions that balance innovation, compliance, and patient safety-making a tangible impact in healthcare.
Engineer III - NPI Manufacturing
Staff engineer job in Andover, MA
Title: Engineer III - NPI Manufacturing
Duration: 6 months+ (possible extension)
Shift: Monday-Friday (8:00 am- 5pm)
Responsibilities:
Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.
Participate in DFM and DFA activities to define manufacturing processes for new product and product enhancement programs.
Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met.
Must haves:
Bachelors Degree at a Minimum
Only Candidates with a Medical Device Background
5+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment.
Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment.
Test Method Validation and Verification (TMV, V&V)
Principal Engineer, Device Development
Staff engineer job in Woburn, MA
Vaxess is an NIH and venture-funded company developing a pipeline of next-generation therapeutics on the Microneedle Array Patch (MAP) platform. With only five minutes of wear-time on the skin, the self-applied MAP enables sustained delivery in the skin. The platform combines high 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.
Device development at Vaxess is cross-disciplinary, integrating mechanical engineering, biomedical engineering, chemical engineering, biomaterials, chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated engineer with a proven track record in medical device development to support the design of our novel delivery system.
Responsibilities
Work under the VP of Device Development to design the re-usable MAP delivery device. Focus for this role will be on product design, development, and design for high volume manufacturability.
Support product development in support of pre-clinical and clinical studies.
Work closely with the multidisciplinary Vaxess team and external consultants with specialties spanning Human Factors, Industrial Design, Packaging, Manufacturing, Engineering, Biocompatibility, Quality, and Regulatory.
Lead the selection and management of outside vendors.
Generate all required documents to support device related components of design control requirements (21 CFR 820, ISO 13485 ISO 14971) and regulatory requirements for combination products (21 CFR Part 4).
Develop test methods, generate and maintain design specification, write protocols & reports, lead prototype generation, design verifications & validations, conduct FMEA's, etc. in line with ISO 14971 Risk Management.
Conduct activities within a quality management system following 21CFR820 Quality System Regulation.
Mentor junior team members in the drug-device combination process.
Qualifications
BS in Mechanical or Biomedical Engineering, with at least 7 years of direct experience leading the development of medical devices, ideally drug-device combination products.
Understanding of material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 is required.
Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations.
Collaborative problem solving, risk assessment, and risk management skills.
Proven time management skills and ability to achieve goals within timelines.
Demonstrated abilities to learn new skills and fields and creatively solve challenging technical problems.
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.
Vaxess aims to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.
If you're interested in joining the Vaxess team, please submit your CV/resume to
******************
.