Job Description
We've been earning the trust of employers since 1985. Find out why they continue to partner with DAVIS.Our team is focused, professional and specialized in a variety of industries, visit a specific page or start with the overview.Find out what we do, how we got started and why businesses and professionals choose DAVIS.Check out our library of valuable resources for employers, employees and job seekers.Choose the location most convenient to you and get started on your job or talent search.Search JOBSSenior Systems Engineer – Medical DevicesJob DescriptionLocation: Bedford, MassachusettsType: Direct HireJob #68161Salary: $180,000Are you an experienced and motivated Engineer with a track record of success leading product development initiatives throughout the full lifecycle for Class 3 medical devices? Would you like to be a critical member of a collaborative team moving a cutting edge product through FDA clearance and beyond? If this sounds like you, apply to this posting with your resume today to be contacted!The Senior Systems Engineer will spearhead the development of new product development efforts for Class 3 medical device products. This role involves the preparation and maintenance of engineering documentation, support of design verification and validation activities including interfacing with external vendors, third party test labs, and internal functions, and ensuring that best engineering practices and efficient processes are employed to meet technical and business objectives.Duties and ResponsibilitiesThis may include but is not limited to the following:Design & Development: Lead the design and development of a medical device with electrical, software and mechanical features.Project Management: Prepare and execute project plans for product development, including defining design concepts, synthesizing marketing input, generating design input, and supporting design verification and validation. Identify appropriate internal and external resources required to efficiently conduct design and development efforts.Coordination: Oversee and coordinate device development with catheter development to ensure comprehensive system product requirements are met.Technical Leadership: Provide technical leadership and direction to engineers, technicians, and consultants involved in device design and development.Documentation & Compliance: Generate and update design input and risk management documents. Support the compilation and submission of regulatory filings and patents.Verification & Validation: Support system-level design verification and validation efforts. Devise and perform analysis and testing of design outputs to justify design input requirements and design decisions.Design Improvements: Analyze data for conformance to design specifications and recommend and implement design improvements to product platforms.Consulting: Provide consulting support to other product development groups for regulatory compliance, quality system, and supply chain management responsibilities.Skills/CompetenciesEducational Background: B.S. in engineering discipline (e.g., Electrical, Mechanical, Biomedical, Software). M.S. preferred.Experience: 10+ years' experience in medical device product development, including FDA regulated devices covered by 510(k) or PMA. Experience with mechanical, electrical, and software systems required; experience with catheter technologies preferred.Leadership: Proven effective motivational leadership skills, with experience in building and managing teams to deliver product designs on schedule.Job DescriptionDAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace. We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be. Apply today and experience “The DAVIS Difference”.Your Name:Email Address:Phone Number:Upload Resume File:Upload Resume File: …Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.By submitting this application, you give us permission to store your personal information and use it to consider your suitability for the position, including sharing it with the hiring firm. You acknowledge and agree to receive our communications via phone, SMS, and email.People looking for jobs should not put anything here.We are uploading your application. It may take a few moments to read your resume. Please wait!As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.The Davis Companies
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