Mechanical Engineer

Kelly; Raynham (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Vacation and sick pay

Paid holidays

401(k) plan

Group medical, vision, dental, life, &

Short-term disability insurance

Kelly Discounts on goods and services

Kelly Learning Center offers free

Job summary

Kelly is seeking 1–2 R&D Engineers to support a manufacturing transfer project for orthopedic sports medicine devices. The role requires medical device development experience, preferably in orthopedics, and a strong understanding of design transfer, V&V, change control, and regulated product development.

You will work with Regulatory Affairs, Quality Engineering, Manufacturing, and R&D to develop and approve key documentation, lead CCPs and CCRs, and coordinate stakeholders to ensure timely

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience in R&D engineering within a regulated medical device environment.
• Experience with orthopedic devices and manufacturing/design transfer.

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 design verification/validation rationales as applicable.
• Author and coordinate CCPs and CCRs.
• Lead cross-functional discussions to align stakeholders on change-control activities.
• Participate in core project team and sub-team meetings.
• Draft technical strategies, rationales, plans, reports, and other regulated documentation.

Skills

R&D engineering

Regulated medical device

Change control

V&V processes

Cross-functional teamwork

Documentation

Education

Bachelor's degree in Engineering

Tools

Windchill PLM

Creo CAD

PLM system

Job description

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.

**MUST HAVE PRIOR MEDICAL DEVICE OR ORTHO DEVICE EXPERIENCE**

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.
• 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, LinkedIn and Twitter.

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.