Kelly Services Mechanical R&D Medical Device Engineer in Raynham, Massachusetts
Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Mechanical R&D Engineer for a long-term engagement at one of our Global clients in Raynham, MA. This would be a contract working remotely for now.
This role is a full-time, fully benefitted 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.
As a Mechanical R&D Engineer placed with KellyOCG you will be responsible for the following:
Mechanical R&D Engineer
Working in the Product Development team the qualified candidate for this position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This individual should be willing to make a significant contribution to a cross functional team, must be self-motivated to take action, and have excellent written and verbal communication skills. Candidate will support efforts to ensure EU MDR compliance.
Must have medical device product development experience and experience with Medical Device Regulations as well as DHF.
POSITION DUTIES & RESPONSIBILITIES:
Review and approval of documentation to support Technical Document to meet MDR requirements
Documents to include (not limited to) Risk Management (design and process), validation, product drawings, performance testing, trace matrix, material specifications, biocompatibility reports, CER (Clinical Evaluation Report), IFUs, surgical technique, manufacturing process information
Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements
Participate in cross functional teams to discuss and revise documents to meet MDR requirements
Create, review and approve engineering rationales/memos as required
Independently assess documentation to determine if it meets MDD/MDR requirements (assess gaps), determine best method to meet requirements and execute the plan.
Ascertain if rationales are required, create or review rationales, approve as required
Work towards quarterly goals, provide weekly task updates and project status.
Suggest means to streamline processes and document approvals
Support risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting.
Revise, review and approve verification and validation activities as required.
Review and approve any required drawing updates, including design impact assessments.
Review and approve any labeling updates, including design impact assessments.
Deliverables to be quarterly based on assigned files.
Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required.
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Report task progress and status on a weekly basis.
EDUCATION & EXPERIENCE REQUIREMENTS:
A minimum of a Bachelor’s of Science degree in Mechanical Engineering, or other technical discipline is required. An Advanced Degree is preferred.
A minimum of 1-3 years of professional experience in engineering is required (not including co-op, internship and research).
Prior experience in Product Development role is required.
Must be experienced with product design and all components of product design including documentation for design controls and Design History Files.
Experience with all the design and development aspects of a series of projects through all phases of the product development process; planning and executing projects or portions of projects from concept through commercialization, and into post-market surveillance.
Position requires the ability to understand and review the product development outputs for user needs and clinical requirements, as well as associated verification and validation activities. Candidate must have knowledge of product development documentation requirements and the manufacture of medical instruments and implants to meet the needs of surgeons & patients.
This individual will also be involved with the review and revision of design verification and validation documentation and test reports that support regulatory review for US and global registration effort.
Candidate will support efforts to ensure EU MDR compliance. Must have a strong compliance background and experience with Medical Device Regulations.
Candidate must also possess knowledge of applicable ASTM/ISO standards (i.e., biocompatibility standards). Engineer will need to ensure standards are appropriate and review documentation of evidence that the standards are met and documented appropriately.
This individual should have a demonstrated ability to prioritize tasks and manage a varied workload, exhibit strong written and verbal communication skills and interface effectively with project teams, management and surgeons.
Experience working within a regulated industry is required; and Medical Device, Spine or Orthopedic experience is preferred.
The ability to work and execute projects tasks within a cross functional environment is required.
Prior experience working cross functional project teams, bringing products from concept to launch, is preferred.
Strong written and verbal communication skills are required, as is the ability to effectively communicate with cross-functional teams and program managers.
Proficiency utilizing MS Office Suite (Word, Excel, PowerPoint etc.) is required.
Knowledge of CAD software is preferred; Unigraphics/NX is preferred
Experience reviewing and approving Change Orders through a PLM System (Adaptiv, Windchill) is required
Previous experience with remediation efforts to meet EU MDD/MDR
Strong design/quality engineering skills with a proven track record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management are required.
Working knowledge of Design Controls, GMPs, QSR (21 CFR 820), MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is preferred.
Working knowledge of material science and mechanical product knowledge is preferred.
Blueprint literacy including GD&T is preferred.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch.
Applicants must be legally permitted to work in the United States immediately and without employer sponsorship (F1 OPT cannot be considered for this position).
Why Kelly ® ?
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we’re here every step of the way to find your dream engineering job.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
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