Manager: Biomedical Hardware and Firmware Design Engineer
Edgewood - Supervise growing R & D Department and design, develop & manufacture medical devices. Responsible for project from concept to release. Use Analog – Digital design, signals – systems & transformation, Biomedical sensors, transducers & instrumentation design, Bio-Optics, Bio-materials & Bio-compatibility. Use MATLAB, LabVIEW, Schematics & PCB layout in NI CAD tools, Solidworks. Li-Ion / alkaline battery design. Use Embedded Firmware programming and Various communication protocol skills + IEC 60601 medical device electrical safety; Risk management, FMEA, usability, ground/insulation withstand, Software-Hardware validation, create documentation - ECO, WI, IFU, tech specs, QSR as per 21 CFR, 510K & clinical trials. Master’s degree (M.S.) in Biomedical or Electrical Engineering + 1 yr exp. Send resume to firstname.lastname@example.org or mail to: Parkell, Inc., 300 Executive Drive, Edgewood, NY 11717
Regulatory Affairs Specialist
The Regulatory Affairs Specialist assists in writing, submitting and gaining clearance for 510(k) submissions and to the Food and Drug Administration (FDA) for class II products. This position entails development of FDA submissions, CE Technical Files and Clinical Evaluations, requiring working knowledge of products under review and of relevant regulations and guidance documents. This position will report to the Quality & Regulatory Affairs Manager.
- • Work with Product Development, Quality Assurance, and Management to prepare, review and maintain international Regulatory submissions, including CE Technical Files and Design Control documents, and other international filings, to obtain and maintain market access.
- • Obtain timely market access for products in parallel with US submissions.
- • Create and submit documents and timely responses with international Regulatory bodies, in accordance with local and international regulations.
- • Support QA/RA Manager in QMS activities: internal auditor, CAPA system, Complaints, and SOP revisions.
- • Provide Regulatory oversight of changes in manufacturing facilities, processes, and procedures, as these changes pertain to international regulations.
- • Creation, review, and submission of product files for foreign market registration.
- • Review design changes and technical files for updates to documentation.
- • Ensure conformance to ISO, CE, FDA and other international/local regulations.
Qualifications: Education - Experience
- • BS degree in Chemistry, Electrical Engineering or health or science-related field. Engineering degree is a plus.
- • Minimum of 4 years experience in the medical device industry.
- • Minimum of 2 years experience in International Regulatory Affairs for the medical device industry. Ideally, have knowledge of requirements in accordance with FDA, MDD/MDR, International standards (ISO 13485), MDSAP, and guidance documents (MEDDEVs).
Qualifications: Knowledge, Skills and Abilities Required
- • Self-starter with excellent ability to work independently with little oversight, as well as excellent organizational, planning, and follow-up skills.
- • Excellent verbal and written communication skills.
- • Strong attention to detail.
- • Desire for continued learning and strength in exhibiting a positive attitude.
- • Strength in prioritizing and handling several projects concurrently and in meeting strict deadlines.
- • Ability to work effectively in a team environment and communicate with team members and customers at all levels of the organization.
- • Proven problem-solving skills.
- • Ability to take ownership of her/his responsibilities.
- • Ability to maintain confidentiality in dealing with regulatory and clinical documentation.
- • Strong technical system skills (e.g. word documents, spreadsheets, online research)
Salary: Commensurate with experience. Competitive compensation package and benefits including excellent health &dental coverage and pension plan. No phone calls please. Email your cover letter, resume and salary requirements to email@example.com or fax to 631-389-1595. Only resumes with cover letters and salary requirements will be considered. Parkell is an EOE.