Vacancy expired!
Kelly Outsourcing & Consulting Group (KellyOCG) , a managed solution provider and a business unit of Kelly Services, Inc., is currently seeking an Medical Device Mechanical NPD Engineer.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.Mechanical Product Development EngineerWorking 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.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, 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.
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, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just 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 , 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/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
Vacancy expired!