Engineering Structures Jobs in Ma

Granite delivers advanced communications and technology solutions to businesses and government agencies throughout the United States and Canada. We provide exceptional customized service with an emphasis on reliability and outstanding customer support and our customers include over 85 of the Fortune 100. Granite has over $1.85 Billion in revenue with more than 2,100 employees and is headquartered in Quincy, MA. Our mission is to be the leading telecommunications company wherever we offer services as well as provide an environment where the value of each individual is recognized and where each person has the opportunity to further their growth and achieve success.

Granite has been recognized by the Boston Business Journal as one of the "Healthiest Companies" in Massachusetts for the past 15 consecutive years.

Our offices have onsite fully equipped state of the art gyms for employees at zero cost.

Granite's philanthropy is unparalleled with over $300 million in donations to organizations such as Dana Farber Cancer Institute, The ALS Foundation and the Alzheimer's Association to name a few.

We have been consistently rated a "Fastest Growing Company" by Inc. Magazine.

Granite was named to Forbes List of America's Best Employers 2022, 2023 and 2024.

Granite was recently named One of Forbes Best Employers for Diversity.

Our company's insurance package includes health, dental, vision, life, disability coverage, 401K retirement with company match, childcare benefits, tuition assistance, and more.

If you are a highly motivated individual who wants to grow your career with a fast paced and progressive company, Granite has countless opportunities for you.

EOE/M/F/Vets/Disabled

General Summary of Position:

Granite is a leading provider of managed security and networking platforms. The NetOps team supports a wide range of technologies and services including Fortinet SD-WAN, Palo Alto, Cisco, and Juniper. Within this team, the Application Automation practice focuses on improving operational efficiency and scalability through scripting, automation, and tool development. This position plays a key role in supporting large enterprise environments by developing automation frameworks, streamlining complex deployments, and reducing manual intervention in day-to-day operations. Responsibilities include solution design, automation development, support for new product rollouts, Tier 3 escalations, and collaboration with engineering teams to build repeatable, efficient processes.

Duties and Responsibilities:

• 
  
• Design, develop, and maintain automation scripts and tools to support network deployments, configuration management, and troubleshooting.
  
• Collaborate with engineering and operations teams to identify repetitive tasks and build automated solutions to reduce manual workload.
  
• Support new technology rollouts by creating scalable deployment frameworks and configuration templates.
  
• Respond to Tier 3 technical escalations, particularly those involving process inefficiencies, integration challenges, or repeat issues solvable via automation.
  
• Research and test emerging network automation technologies to improve toolsets and practices.
  
• Document automation procedures, scripts, and best practices for operational consistency and knowledge sharing.
  
• Ensure all automated solutions align with security and compliance standards.
  
• Participate in audits and reviews to ensure reliability and maintainability of automation systems.
  

Required Qualifications:

• 
  
• Bachelor's degree in computer science, Network Engineering, or a related field.
  
• Proficiency in scripting languages such as Python, Bash, or PowerShell.
  
• Strong understanding of APIs, network configuration models (e.g., NETCONF, RESTCONF), and configuration automation tools (e.g., Ansible, Terraform).
  
• Experience supporting enterprise-grade networks, preferably in a service provider or managed services environment.
  
• Demonstrated ability to troubleshoot complex network issues and implement automated solutions.
  
• Excellent communication and documentation skills
  

At a Glance

Company: Karl Storz
Location: Franklin, MA (On-site)
Job Type: Full-Time
Pay Range: $97,900 – $127,400 per year (DOE)
Shift: Day Shift | Monday – Friday
Overtime: As Needed
Experience Level: Senior (5+ years machining/manufacturing experience)
Education: Bachelor’s Degree Required (Mechanical or Industrial Engineering)
Industry: Medical Device Manufacturing
Apply: Directly through hireCNC

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Why This Role Exists

This role exists to support ongoing product innovation, process optimization, and production scalability within a high-precision medical manufacturing environment.

At Karl Storz, this Process Engineer plays a key role in developing, improving, and sustaining CNC machining processes used to produce complex surgical components — ensuring efficiency, quality, regulatory compliance, and long-term manufacturability.

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The Work You’ll Be Doing

In this role, you will:

• 
  
• Develop machining processes and operation sheets from engineering data
  
• Implement new manufacturing methods, tooling, and equipment improvements
  
• Optimize processes for quality, efficiency, and cost reduction
  
• Design assembly tooling, jigs, fixtures, and production aids
  
• Lead cross-functional projects from concept through implementation
  
• Analyze manufacturing data and drive corrective actions with Quality teams
  
• Evaluate outside processes and vendors for performance and reliability
  
• Support capacity planning and equipment selection decisions
  
• Create clear documentation to support production and compliance
  
• Train personnel and provide daily technical support to production teams
  
• Ensure compliance with FDA, ISO 13485, ISO 9001, and GMP standards
  

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Machines, Controls & Manufacturing Environment

You’ll support machining operations involving:

Equipment: Multi-axis CNC mills, lathes, and precision machining systems
Inspection Tools: CMM, profilometers, vision systems, precision metrology equipment
Process Tools: SPC methods, Lean manufacturing techniques
ERP Systems: SAP, Oracle, or similar

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Materials You’ll Work With

• 
  
• Stainless Steel
  
• Nitinol
  
• Nickel Alloys
  
• Other medical-grade materials
  

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What We’re Looking ForRequired:

• 
  
• Bachelor’s degree in Mechanical or Industrial Engineering
  
• 5+ years of manufacturing or machining-related experience
  
• Strong knowledge of CNC machining processes and equipment
  
• Proficiency with GD&T and precision metrology
  
• Experience developing and improving manufacturing processes
  
• Strong documentation and project management skills
  
• Ability to manage multiple priorities in a regulated environment
  
• Excellent communication and cross-functional collaboration skills
  

Preferred:

• 
  
• Medical device manufacturing experience
  
• Lean Manufacturing or Six Sigma certification
  
• Fixture and tooling design experience
  
• GMP / FDA-regulated environment experience
  
• ERP experience (SAP or Oracle)
  

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Why Engineers Like Working Here

Professionals choose Karl Storz because:

• 
  
• Clean, modern, climate-controlled manufacturing facility
  
• Meaningful work supporting life-saving medical technologies
  
• Strong collaboration between engineering, production, and quality
  
• Stable workload with long-term growth opportunities
  
• Competitive salary and comprehensive benefits
  
• Tuition reimbursement (up to $5,250/year)
  
• 401(k) with 60% match on first 6%
  
• 3 weeks vacation + 11 paid holidays
  
• Up to 8 weeks fully paid parental leave
  

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Pay, Benefits & Schedule

Pay Range: $97,900 – $127,400 per year (based on experience)

Benefits Include:

• 
  
• Medical, dental, vision
  
• 401(k) with company match
  
• PTO + paid holidays
  
• Tuition reimbursement
  
• Parental leave
  
• Life, STD/LTD insurance
  
• Flexible Spending Accounts
  
• Wellness and fitness reimbursement
  
• Pet insurance options
  

Schedule:
Day Shift | Monday – Friday

Overtime: As needed

---

Apply

Interested candidates can apply directly through hireCNC.

Apply Now or Save This Job to come back later.

Sr. Project Manager

Location: Boston, MA (candidates must already reside in Massachusetts, preferably in the Boston area)

Schedule: 100% onsite at the main office or hospital project sites

Travel:

40–60% travel within approximately one hour of the main office to various hospital project sites. Mileage reimbursement provided.

Compensation

• $128K–$155K base salary
• Discretionary annual bonus
• $452/month vehicle allowance
• $80/month phone allowance

Overview

Large hospital construction project within the Boston metro area, consisting of multiple project sites.

Required Experience

• 8+ years of project management experience with a mechanical subcontractor
• Experience managing hospital construction projects valued at $5M+ (other commercial project types will not be considered)
• Strong experience managing subcontractors, vendors, budgets, and client relationships

Education

Bachelor’s degree in Construction Management, Engineering, Architecture, or related field.

Equivalent HVAC or plumbing field experience may be considered.

Preferred Certifications

• PMP (Project Management Professional) – PMI
• Procore Certified
• OSHA 30, CPR, and First Aid (preferred)

Key Responsibilities

• Oversee all aspects of project delivery including financial management, subcontractors, vendors, and client relationships
• Maintain job site safety through safety planning, JHA approvals, toolbox talks, and site walks
• Manage project budgets and contract delivery types (GMP, Lump Sum, or Concession Agreement)
• Ensure contract compliance including insurance, reporting, scheduling, and energy savings requirements
• Oversee Procore project setup, including change management and document control
• Negotiate and execute vendor purchase orders and subcontracts
• Lead project handoff meetings and ensure alignment on project goals and client expectations
• Oversee site utilization planning with emphasis on safety, cleanliness, and access control
• Establish and manage the project baseline schedule and milestone tracking
• Lead monthly project reporting, cost reviews, and risk mitigation planning
• Ensure execution of the project quality assurance plan
• Manage change processes including RFIs, drawing revisions, and client directives
• Lead project meetings and distribute agendas and minutes
• Build and maintain relationships with subcontractors, vendors, and clients
• Manage and mentor Project Managers

Qualifications

• 8+ years of relevant experience
• Ability to manage multiple priorities and resolve project challenges effectively
• Proficiency with Microsoft Office and Procore

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match (100% of the first 3%, 50% of the next 2%)
• 120 hours PTO and 9 paid holidays
• Mileage reimbursement and monthly vehicle allowance.

Granite delivers advanced communications and technology solutions to businesses and government agencies throughout the United States and Canada. We provide exceptional customized service with an emphasis on reliability and outstanding customer support and our customers include over 85 of the Fortune 100. Granite has over $1.85 Billion in revenue with more than 2,100 employees and is headquartered in Quincy, MA. Our mission is to be the leading telecommunications company wherever we offer services as well as provide an environment where the value of each individual is recognized and where each person has the opportunity to further their growth and achieve success.

Granite has been recognized by the Boston Business Journal as one of the "Healthiest Companies" in Massachusetts for the past 15 consecutive years.

Our offices have onsite fully equipped state of the art gyms for employees at zero cost.

Granite's philanthropy is unparalleled with over $300 million in donations to organizations such as Dana Farber Cancer Institute, The ALS Foundation and the Alzheimer's Association to name a few.

We have been consistently rated a "Fastest Growing Company" by Inc. Magazine.

Granite was named to Forbes List of America's Best Employers 2022, 2023 and 2024.

Granite was recently named One of Forbes Best Employers for Diversity.

Our company's insurance package includes health, dental, vision, life, disability coverage, 401K retirement with company match, childcare benefits, tuition assistance, and more.

If you are a highly motivated individual who wants to grow your career with a fast paced and progressive company, Granite has countless opportunities for you.

EOE/M/F/Vets/Disabled

Job Description

We are seeking a highly skilled and experienced Lead AI Engineer to join our dynamic team. The ideal candidate will excel at identifying and articulating complex business problems, and will develop innovative, scalable, and robust AI/ML solutions to address these challenges. Responsibilities will include designing, building, and deploying enterprise-grade AI systems, specifically focused on:

• 
  
• Agentic AI solutions to automate operational processes (e.g., interpreting trouble tickets, performing basic troubleshooting, interacting with online portals, data entry).
  
• Retrieval-Augmented Generation (RAG) and ColBERTv2 pipelines for parsing, indexing, and querying enterprise documents to facilitate answers related to process guidelines, product knowledge, and training materials.
  
• Function calling solutions leveraging Large Language Models (LLMs) to automate and perform precise actions in enterprise workflows.
  
• Developing and applying reinforcement learning strategies to optimize and automate decision-making processes within enterprise operations.
  

This role requires hands-on expertise with model fine-tuning, training pipelines, post-training optimization techniques (e.g., model distillation), classification models, and integrating AI systems within complex enterprise environments.

Duties and Responsibilities

• 
  
• Develop and implement AI solutions leveraging fine-tuned Large Language Models (e.g., OpenAI models, LLaMA, Mistral).
  
• Design, develop, and optimize Retrieval-Augmented Generation (RAG) pipelines using advanced vector databases (e.g., FAISS, Pinecone, Milvus).
  
• Build and enhance agentic AI systems utilizing frameworks like LangChain, AutoGPT, or similar automation frameworks.
  
• Deploy scalable ColBERTv2 architectures for semantic retrieval and classification.
  
• Create robust pre-processing and post-processing pipelines to enhance model performance, accuracy, and interpretability.
  
• Collaborate closely with cross-functional teams, including product managers, business stakeholders, data scientists, and software engineers.
  
• Implement best practices in model distillation, quantization, and optimization for deployment in production environments.
  
• Ensure compliance with enterprise-grade security, privacy standards, and data governance practices.
  
• Provide leadership and mentorship to team members, supporting their technical development and career growth through coaching, training, and performance feedback.
  
• Drive timely and successful completion of AI/ML projects by setting clear milestones, tracking progress, removing blockers, and aligning resources
  

Required Qualifications

• 
  
• Bachelor's degree in Computer Science, Data Science, Machine Learning, AI, or related fields; advanced degree strongly preferred.
  
• 5+ years of proven experience developing and deploying production-grade AI/ML systems.
  
• Strong programming skills in Python, familiarity with libraries/frameworks such as PyTorch, TensorFlow, Hugging Face, and LangChain.
  
• Demonstrated expertise with LLM fine-tuning (e.g., LoRA, PEFT), distillation, and model optimization.
  
• Practical experience implementing RAG pipelines with embedding technologies and vector stores (e.g., FAISS, Pinecone).
  
• Proven track record building agentic AI systems capable of interacting with multiple enterprise applications and platforms.
  
• Solid understanding of NLP techniques, Transformer architectures, semantic search, and document retrieval technologies (e.g., ColBERT).
  
• Hands-on experience with reinforcement learning techniques, including designing, training, and deploying reinforcement learning models.
  

Preferred Qualifications:

• 
  
• Master's or Ph.D. in Computer Science, Machine Learning, Artificial Intelligence, or related field.
  
• Familiarity with cloud-based AI services (e.g., AWS SageMaker, Azure ML, Google Vertex AI).
  
• Experience with containerization (Docker, Kubernetes) and deployment pipelines (CI/CD).
  
• Knowledge of advanced AI frameworks and model inference engines such as Triton Inference Server, TensorRT, and ONNX.
  
• Familiarity with model monitoring, observability tools, and techniques to ensure long-term reliability and performance.
  
• Strong communication and interpersonal skills with the ability to clearly articulate complex technical solutions to non-technical stakeholders.
  
• Experience in regulated industries or environments requiring strict compliance and data governance standards.
  

Our client, a fast-paced leader in product development, is seeking a Manufacturing/Process Engineer to join their very busy team. The Manufacturing/Process Engineer will support the transition of products from engineering to manufacturing and will be responsible for bringing new products from Design Verification build to Pilot Production. Additionally, the Manufacturing/Process Engineer will support the design, installation, and operation of production processes, including sheet metal fabrication, foaming of refrigeration enclosures, heat pipe assembly, electro-mechanical assembly, and performance testing. They will also collaborate with engineers in Design for Manufacturability to transition new products from Design Verification builds into Manufacturing Validation builds and Mass Production, as well as work in a multidisciplinary production and development team.

To be successful in this role, candidates will utilize SolidWorks to produce deliverables, including production assembly procedures, and will also provide technical training to the production staff for all new product introductions to enhance product quality and maximize production efficiency. In this very important role, candidates must be experienced engineers who can work independently and communicate clearly with managers, co-workers, and clients. Candidates with an Engineering degree in Mechanical, Manufacturing, or Industrial Engineering, and at least 10 years of manufacturing engineering experience, will be considered. Please apply if you meet these qualifications and are local to the Greater Boston area.

Additional Responsibilities and Qualifications

• Troubleshoot and resolve production line failures and technical issues.
• Design and implement functional fixtures and gauges to increase efficiency, improve quality, and minimize defects.
• Support the installation, programming, and maintenance of production equipment and materials.
• Lead continuous improvement initiatives for production line defects and field failures.
• Support the implementation of an ERP system and process ERP data to reinforce a lean manufacturing environment.
• Analyze production times, shop layout, and costs to provide reports for operational decisions.
• Collaborate with engineers to improve control processes for existing products and implement new control processes for new product introductions.
• Experience with refrigeration systems and foaming tools is preferred.
• Experience with various fabrication processes such as vacuum forming, injection molding, sheet metal forming, and rapid prototyping methods
• Working knowledge of Lean Manufacturing and Six Sigma principles is preferred.
• Ability to generate robust mechanical drawings, assembly procedures, and written reports. 3D CAD experience is a must. SolidWorks proficiency required.
• High level of personal commitment to quality, with demonstrated thoroughness and attention to detail in all phases of a process or project.
• Excellent communication and interpersonal skills, highlighted by a flexible and collaborative working style.
• Due to the nature of the work, citizenship or legal residents only will be considered.

Adecco Permanent Recruitment is partnering with a well-established Massachusetts-based contractor specializing in large-scale renewable energy and electrical utility projects. Our client is seeking experienced Project Managers and Senior Project Managers to oversee the planning and execution of complex electrical distribution, substation, and solar construction projects across the U.S. This position offers hybrid flexibility, competitive compensation, and a collaborative environment that values innovation, safety, and technical excellence.

Key Responsibilities

• Manage all phases of construction projects, including budget, schedule, scope, subcontractor coordination, and safety compliance.
• Oversee multiple concurrent renewable energy and utility-scale projects, ranging from under $1M to $25M.
• Lead and mentor Construction Managers and field teams, ensuring consistent project execution and communication.
• Coordinate between corporate engineering, estimating, and field operations to maintain alignment on project objectives.
• Conduct constructability reviews, value engineering analyses, and risk assessments to improve delivery outcomes.
• Track progress against milestones, review submittals and RFIs, and ensure adherence to design, code, and contract requirements.
• Support project documentation, reporting, and client communications throughout the lifecycle of each project.

Qualifications and Must-Haves

• 3+ years of project management experience in construction, ideally within electrical utility distribution, substation, or renewable energy (solar) sectors.
• Bachelor’s degree in Electrical Engineering or related discipline preferred.
• Strong proficiency in MS Word, Excel, Project, and PowerPoint; experience with Primavera or construction management software a plus.
• Demonstrated experience managing CPM schedules, budgets, and documentation (RFIs, submittals, cost tracking).
• Proven ability to lead project teams and communicate effectively with clients, engineers, and contractors.
• OSHA safety training preferred.
• Experience with federal, state, or large-scale infrastructure contracts a strong advantage.

Benefits: Health Insurance, Accrued Vacation Time, Employer-Matched 401(k), Bonus Eligibility

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

The Quality Director is responsible for leading all aspects of the company’s quality management program, including inspection, testing, quality assurance, and continuous improvement over 3 manufacturing sites. This is a hands-on leadership position that requires both strategic oversight and direct involvement in inspection and problem-solving activities on the production floor. The Quality Director ensures that products consistently meet customer requirements, internal standards, and applicable regulatory and industry certifications.

Key Responsibilities:

· Champion and uphold the company’s values, vision, mission and quality policy in all activities.

· Adhere to and help enforce company policies, procedures, and internal control standards.

· Direct and manage all activities within the Quality Department, including Quality Engineers, Inspectors, and Technicians.

· Establish department goals, KPIs, and quality objectives that align with company strategy.

· Develop, coach, and evaluate team members to ensure competence, engagement, and accountability. Lead by example, maintaining a visible and active presence on the production floor.

· Oversee and participate in first article, in-process, and final inspections to verify compliance with specifications and drawings.

· Interpret engineering drawings and specifications, including GD&T.

· Use precision measurement tools (calipers, micrometers, indicators, CMMs, gauges, etc.) to verify part conformance.

· Develop, maintain, and continuously improve inspection plans, work instructions, and sampling procedures.

· Maintain calibration and control of all inspection equipment.

· Manage and maintain the company’s QMS in compliance with ISO9001:2015, ISO 13485:2016 and AS9100D (and/or industry-specific standards).

· Lead internal and external audits, ensuring audit findings are documented, corrected, and closed on time.

· Oversee documentation control, ensuring policies, procedures, and records are current and accurate.

· Prepare and submit quality reports and performance metrics to senior leadership.

· Lead root cause analysis and corrective/preventive actions (CAPA) for nonconformances and customer issues.

· Collaborate with production, engineering, and supply chain teams to resolve quality issues and prevent recurrence.

· Drive initiatives to reduce scrap, rework, and process variation.

· Utilize Lean, Six Sigma, or other quality tools to identify and implement process improvements.

· Serve as the primary point of contact for customer quality concerns, audits, and certifications.

· Investigate and resolve customer complaints with professionalism and urgency.

· Manage supplier quality performance and assist with incoming inspection or supplier corrective actions as needed.

· Collect, analyze, and report key quality performance indicators (defect rates, rework, scrap, returns, etc.).

· Use data to identify trends, recommend improvements, and support operational decision-making.

Qualifications:

· Bachelor’s degree in Engineering, Quality Management, or related technical discipline; equivalent experience considered.

· Minimum 7 years of progressive quality experience in a manufacturing environment, including at least 3 years in a leadership role.

· Strong hands-on inspection skills and understanding of dimensional measurement tools and techniques.

· Proven ability to read and interpret complex blueprints and apply GD&T principles.

· In-depth knowledge of ISO9001:2015, ISO 13485:2016 and AS9100D and quality management systems.

· Experience with corrective actions, root cause analysis, and continuous improvement methodologies.

· Excellent leadership, communication, and team-building skills.

· Proficiency in Microsoft Office and quality software systems (SPC, CMM, or QMS software).

· Demonstrated ability to interact effectively with customers, suppliers, and all levels of internal personnel.

· Experience in plastics, precision machining, or manufacturing for regulated industries.

· Experience with PPAP, FMEA, control plans and other advanced quality planning tools.

Work Environment:

· Work environment includes manufacturing and warehouse settings with exposure to machinery, moderate noise and variable temperatures.

· Must be able to stand and move between production and office areas frequently.

· Hands-on leadership expected.

· May involve standing for long periods, lifting up to 50 lbs, and working near machinery.

Expected Hours of Work:

· This is a full-time position, typically Monday through Friday. While weekend work is rare, occasional weekend activity may be required based on business needs.

Travel:

· 10%

· Possible international travel

On-site Burlington, Massachusetts

Ongoing contract on a W-2

We are looking for a Field Engineer that ideally has previous linear water rehabilitation experience i.e. sewers. This will be an onsite role for a sewer rehabilitation project for a utility client in Boston. They will be providing Owner's rep services and be reviewing drawings, RFI's, etc. to provide technical support out in the field to the main contractors out in the field. This person will coordinate back with the design engineer office to determine if changes need to be made.

Provide subcontractors with information and direction, as outlined within contract specifications, to allow the work to proceed as scheduled. Authority to interpret technical requirements and provide solutions in conjunction with discipline Project Department Engineer and Discipline Superintendent, to provide drawings and data, and to direct work as assigned and consistent with Company's contractual commitments. May perform subcontract administration of discipline specific or assigned procurements. Interprets and administers fundamental commercial issues. Position may transition to assistant superintendent or startup engineering role. May perform in an EPC environment where Company is either solely responsible or in a Joint Venture/Consortium with others. Provides technical direction/interpretation of design drawings and specification requirements, as well as general guidance to subcontractors on overall design. May perform fundamental design checks and re-design in the field without supervision. Provides commercial direction, interpretation of subcontracts, and administers discipline specific or assigned contract requirements in coordination with Field. Subcontract Administrator or Procurement Manager. Reviews, maintains records, and responds to Contractor Information. Requests (CIRs) as assigned. Monitors assigned subcontractor(s) for compliance with subcontract technical requirements. Monitors discipline construction activities for compliance with the CPM schedule. Prepares and issues all discipline extra work authorization requests (RFMPs/WAs) with the approval of the Project Field Manager Coordinates with Field. Subcontract Administrator as needed. Maintains a daily log for site record purposes. Completes quantity take-offs as required to support construction planning and invoice approval. Reviews all subcontractor progress payment requests for acceptance. Monitors technical service representative (supplier) daily logs and reviews/approves their timesheets. Compiles and maintains Conformed to Construction Records drawing and list markups as assigned. Directs site document control activities for design documents. Assists Field Quality Assurance Manager in performing inspections and verification of tests. Adheres to safety and quality standards as appropriate for level of duties and accountabilities. Supports continuous improvement efforts and the change management effects associated with the implementation of improvements. Provides commercial direction, interpretation of subcontracts, and administers discipline specific or assigned contract requirements in coordination with Field Subcontract Administrator or Procurement Manager. Reviews, maintains records, and responds to Contractor Information Requests (CIRs) as assigned. Acts in capacity of a "lead person" Does not have management responsibility for the people to whom they provide work direction except as assigned Directs other discipline engineers, general foreman, craft personnel, TA's, and vendor representatives.

Education: MUST have a BS in engineering. Preferrably Civil since it is dealing with underground construction (but not a deal-breaker)

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screeningto the transplant community.

Position Overview: The Design Quality Engineer will play a crucial role in ensuring the quality and compliance of Paragonix's medical device products throughout the design and development lifecycle. The successful candidate will collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to drive excellence in design control processes.

Primary responsibilities/authority will include:

• 
  
• Design Control Compliance: Implement and maintain design control processes in accordance with applicable regulatory standards (e.g., ISO 13485, ISO 14971, FDA QSR, MDR) to ensure the development of safe and effective medical devices.
  
• Risk Management: Lead and contribute to risk management activities throughout the design process, including the identification, assessment, and mitigation of potential risks. Work closely with the R&D team to integrate risk management into the design process.
  
• Failure Analysis: Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending.
  
• Quality Planning: Develop and execute quality plans for new product development projects, outlining quality objectives, deliverables, and verification/validation activities.
  
• Design Input and Output:
  
  • 
    
  • Review and approve design inputs to ensure they are clear, complete, and aligned with user needs and regulatory requirements.
    
  • Validate that design outputs meet the specified design input requirements.
    
  
  
  
• Change Control: Manage design changes by assessing their impact on product quality, ensuring proper documentation, and obtaining necessary approvals.
  
• Verification and Validation:
  
  • 
    
  • Develop and execute protocols for design verification and validation strategies and acceptance criteria.
    
  • Collaborate with testing teams to ensure thorough testing of product designs.
    
  
  
  
• Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to facilitate effective communication and collaboration throughout the product development process.
  
• Regulatory Compliance: Stay abreast of relevant regulations and standards and ensure that product designs comply with applicable requirements. Support regulatory submissions as needed.
  
• Continuous Improvement: Identify opportunities for process improvements within the design control system and contribute to the development and implementation of best practices.
  

Required Qualifications:

• 
  
• Bachelor's degree in engineering or a related field; advanced degree preferred.
  
• Minimum of 1-3 years of experience in a quality engineering role in the medical device industry.
  
• In-depth knowledge of design control processes, risk management, and quality management systems (ISO 13485, ISO 14971, FDA QSR).
  
• Strong technical skills related to product quality including VOE translation to Design Specs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics.
  
• Strong understanding of regulatory requirements for medical devices (FDA, EU MDR, etc.).
  
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
  
• DFSS or DMAIC Black Belt Certified, ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification is a plus.
  

Other Requirements:

• 
  
• Electrical and mechanical background strongly preferred.
  
• Experience creating and analyzing charts in Minitab, JMP, or equivalent software a plus.
  
• Knowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls a plus.
  
• Computer proficiency in MS office (specifically Excel).
  
• Effective verbal and excellent technical writing skills.
  
• Excels at generating and maintaining organized and accurate records.
  
• Excellent oral and written communication skills in English.
  
• Able to travel domestically and internationally as required (