Kelly Services Mechanical Engineer - Product Development in Raynham, Massachusetts
Kelly Services has provided outstanding employment opportunities to the most talented individuals in the marketplace. Today, we are proud to offer 3 contract opportunities for Mechanical Engineers with our client, a leader in the Pharmaceutical/Medical Device industry, located in Raynham, MA.
Positions come with medical benefits, paid time off, including vacation, sick time, and holidays. They are long term roles based on business needs.
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 Medical Device Regulation compliance. Must have medical device product development experience and experience with Medical Device Regulations.
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:
Must have experience in the documentation creating the Design History File- also known as engineering change or enterprise change . (Risk management documents, performance testing, biocompatibility reports, Input/output/verification/validation, etc)
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.
Must be experienced with product design and all components of product design including documentation for design controls and Design History Files.
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.
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 5 years of professional experience in engineering is required (not including co-op, internship and research). Prior experience in Product Development role is required.
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 preferred
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. Must be legally permitted to work in the United States.
Benefits and Perks: You’ll enjoy competitive pay as well as a comprehensive array of benefits for which you may be eligible, including:
Paid Time Off
Online Training via the Kelly Learning Center
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
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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.