Mechanical Engineer

Kelly Services; Raynham (MA); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k) plan

Paid time off

Annual performance reviews

Kelly discounts

Job summary

Kelly Services is seeking 1-2 R&D Engineers to support a manufacturing transfer project for orthopedic sports medicine devices in Raynham, MA. The role involves design transfer, V&V, change control, and regulated product development, with cross-functional collaboration across Regulatory Affairs, Quality, Manufacturing, and R&D.

Responsibilities include preparing CCPs/CCRs, creating technical strategies and documentation, and leading cross-functional teamwork to ensure timely delivery.

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience in medical device R&D within regulated environments.
• Experience with orthopedic devices preferred.
• Experience with manufacturing transfer/design transfer activities.
• Knowledge of V&V processes and documentation.
• Ability to coordinate cross-functional teams.

Responsibilities

• Author Manufacturing Transfer Plans and technical documentation.
• Develop V&V strategies and documentation.
• Develop stability/shelf-life strategies for products and packaging.
• Maintain Requirements and Traceability Matrices.
• Review and approve Process Verification/Process Validation docs.
• Lead CCPs and CCRs and coordinate cross-functional stakeholders.
• Draft technical strategies, rationales, plans, and reports.
• Use document management system to route/approve documents.

Skills

Engineering degree

Medical device development

R&D engineering

Orthopedic devices

Design transfer

Verification & Validation

Change controls

Cross-functional collaboration

Communication skills

Stakeholder management

Education

Bachelor's degree in Engineering

Tools

Windchill PLM

PLM systems

Creo CAD

Job description

Kelly Services is currently seeking 2 R&D Engineers for one of our top clients working onsite in Raynham, MA . Manager is open to hybrid 3xs a week onsite.

• Kelly Outsourcing Consulting Group KellyOCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking 2 R&D Engineers for a 12 month+ engagement at one of our Global clients working onsite in Raynham, MA. This role is a full-time, fully benefited position.
• As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from.
• You’ll also be eligible for paid time off, including holiday, vacation and sick/personal time.
• All KellyOCG employees receive annual performance reviews.

Position Overview

We are seeking 1-2 R&D Engineers to support a manufacturing transfer project for orthopedic sports medicine devices. The ideal candidate will have medical device development experience, preferably within orthopedics, and a strong understanding of design transfer, verification/validation, change control, and regulated product development.

This role will work closely with cross-functional partners including Regulatory Affairs, Quality Engineering, Manufacturing, and R&D to develop, coordinate, review, and approve key technical documentation and deliverables.

A particularly important component of the role will be leading Change Control Plans (CCPs) and Change Control Reports (CCRs) and coordinating cross-functional stakeholders to ensure timely alignment and execution.

Key Responsibilities

• Author Manufacturing Transfer Plans and supporting technical documentation.
• Develop and author Verification and Validation (V&V) strategies.
• Develop and author product and packaging stability / shelf-life strategies.
• Update and maintain Requirements and Traceability Matrices.
• Review and approve Process Verification and Process Validation documentation.
• Develop and document appropriate design verification/validation rationales as applicable.
• Author and coordinate Change Control Plans (CCPs).
• Author and coordinate Change Control Reports (CCRs).
• Lead cross-functional discussions to align R&D, Quality, Regulatory, Manufacturing, and other stakeholders on change-control activities and deliverables.
• Participate in core project team and sub-team meetings.
• Draft technical strategies, rationales, plans, reports, and other regulated documentation.
• Use the company's document management system to read, review, route, and approve documents.
• Support execution of manufacturing transfer activities in a regulated medical device environment.
• Bonus: Conduct and document simulated-use benchtop testing onsite in Raynham, including development/execution of protocols and preparation of test reports.

Top Day-to-Day Activities

• Writing and coordinating Change Control Plans and Change Control Reports.
• Participating in project team and cross-functional sub-team meetings.
• Writing technical strategies, rationales, plans, and reports.
• Reviewing, routing, and managing documentation within the applicable document management system.
• Coordinating with cross-functional stakeholders to keep deliverables aligned and on schedule.

Required Qualifications

• Bachelor's degree in Engineering or a related engineering discipline.
• Professional experience in medical device development.
• Experience in R&D engineering within a regulated medical device environment.
• Experience with orthopedic devices strongly preferred.
• Experience with manufacturing transfer/design transfer activities.
• Working knowledge of medical device verification and validation processes and documentation.
• Experience developing or reviewing change controls, technical plans, and reports.
• Experience working cross-functionally with teams such as R&D, Quality Engineering, Regulatory Affairs, and Manufacturing.
• Strong written and verbal communication skills.
• Ability to manage multiple stakeholders and drive technical deliverables to completion.

Preferred Qualifications

• Experience with orthopedic sports medicine devices.
• Experience authoring CCPs and CCRs.
• Windchill PLM experience is strongly preferred.
• Experience with another Product Lifecycle Management (PLM) system required.
• Experience with Creo CAD is a plus but not required.
• Experience with simulated-use or benchtop testing.
• Ability and willingness to work onsite in Raynham, MA for testing and project activities.

Important information:

This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

Why Kelly®?

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ® ) is one focus within the full array of Kelly Services® workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward‑looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.

As a Kelly Services employee, you will have access to numerous perks, including:

• Vacation and sick pay
• Paid holidays
• 401(k) plan
• Group medical, vision, dental, life, and short-term disability insurance options
• Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools
• Kelly Learning Center offers free courses and trainings
• Weekly pay

About Kelly Services

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook (https://www.facebook.com/kellyservices) , LinkedIn (http://www.linkedin.com/company/kellyservices) and Twitter (https://twitter.com/kellyservices) .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. For more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Find what’s next with Kelly®.

As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.