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25 days old

Mechanical Biomedical Engineer

Kelly Services
Raynham, MA 02767
_Kelly Engineering is currently seeking a_ **_Mechanical Biomedical Engineer_** _for a long-term engagement at one of our Global clients in_ **_Raynham, MA_** _. This role is a full-time, fully benefitted position. 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._


_As a_ **_Mechanical Biomedical Engineer_** _placed with Kelly Engineering you will be responsible for the following:_


**_Mechanical Biomedical engineer, Mid-level, for Manufacturing Transfer R&D support position (Europe site going to Mexico Site)._**


_Working in the Product Development team the qualified candidate for this position should excel in a medical device 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._


**_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 Bachelors of Science degree in Electrical, Electro-Mechanical, or closely related technical discipline is required. An Advanced Degree is preferred_** _._

+ **_A minimum of 4-5 years of professional_** _experience in engineering is required (_ **_not including co-op, internship and research)._**

+ _Will be_ **_remediating input/output matrices and identifying and coordinating testing program (tests to validate the manufacture of devices in new location)._**

+ _Familiarity with clean room assembly desired._

+ _Spanish and/or French fluency a nice to have._

+ _Prior_ **_R&D document remediation_** _and_ **_Product transfer_** _experience._

+ _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 electromechanical surgical equipment (capital equipment) and related sterile disposables 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 electro-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** **** **?**


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, were here every step of the way to find your dream engineering job.


**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 (plus, did we mention we provide a ton of benefits ?). 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.
Posted: 2021-04-12 Expires: 2021-05-13

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Mechanical Biomedical Engineer

Kelly Services
Raynham, MA 02767

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