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1+ months

Mechanical Engineer

Kelly Services
Raynham, MA 02767
  • Jobs Rated
    57th
**_Kelly Outsourcing & Consulting Group (KellyOCG)_** _, a managed solution provider and a business unit of_ **_Kelly Services, Inc.,_** _is currently seeking an_ **_R&D Mechanical Engineer with Medical Device industry expeiernce_** _for a long-term engagement at one of our global medical device clients in_ **_Raynham, MA._**





_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._



_Youll also be eligible for paid time off, including holiday, vacation and sick/personal time._ _All KellyOCG employees receive annual performance reviews._





**_R&D Medical Device Mechanical 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, remediation and experience with Medical Device Regulations as well as DHF._**





**_PO_** **_SITI_** **_O_** **_N 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, remediation, 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_ **_Bachelors of Science degree in Mechanical Engineering, or other technical discipline is required._** _An Advanced Degree is preferred_

+ **_A minimum of 7-10 years_** _of professional experience in_ **_engineering_** _is required_ **_(not including co-op, internship and research)_**

+ _Prior experience in_ **_Product Development_** _role is_ **_required_**

+ _Previous experience with_ **_remediation_** _efforts to meet EU MDD/MDR 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 efforts_

+ _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_**

+ _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/H1B_** _cannot be considered for this position)._






**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 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** ****



At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS

Jobs Rated Reports for Mechanical Engineer

Posted: 2020-08-17 Expires: 2020-10-22

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Mechanical Engineer

Kelly Services
Raynham, MA 02767

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Mechanical Engineer
57th2018 - Mechanical Engineer
Overall Rating: 57/220
Median Salary: $85,880

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