Staff/Principal Biomedical Systems Engineer

Teleflex - Morrisville, NC3.7

Full-timeEstimated: $100,000 - $140,000 a year
Skills
About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Vascular Access – Built on a history of innovation, our Arrow® brand of technically advanced vascular access devices are renowned throughout the world. Many of our vascular access products have antimicrobial and antithrombogenic protection designed to reduce vascular-related complications and include long and short dwell central venous catheters (CVC), sheath introducers, arterial lines, peripherally inserted central catheters (PICC), as well as specialty devices for intraosseous vascular access and an advanced vascular positioning system to facilitate precise placement of a PICC or CVC near the heart. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Provide engineering leadership and hands on capabilities to design and develop of medical device systems including capital equipment and disposables, provide solutions to engineering challenges and coordinate R&D technical projects and release to manufacturing. Design entire systems from user needs and requirements through design, verification/validation, transfer, and sustaining. Participate on product teams as an R&D functional expert for full product lifecycle.

Principal Responsibilities

Contribute, with other team members, on developing product requirements, project planning, system design, prototyping, hazards/risk/DFMEA/PFMEA, verification, validation, and design transfer.
Provide input to project plans and schedules, and contribute systems design deliverables as planned.
Contribute to sustaining/improvements to existing products as needed.
Provide direction to less-senior colleagues in topics such as design, and the technical aspects of project planning.
Contribute to product/project cost estimates.
Direct internal/external resources such as partners/suppliers.
Interface with clinicians and Key Opinion Leaders in effort to identify user needs, new markets opportunities, evaluate new technologies and/or keep current in medical field.
Direct and mentor the efforts of engineers of various levels of experience in the development of products, processes and/or procedures.
Document and protect new product ideas via the intellectual properties process.
Provide technical due diligence expert analysis and reports on new technologies and/or potential business acquisitions.
Interface and effectively communicate with technical and non-technical staff throughout the organization.
Adhere to and ensure the compliance of Teleflex's code of ethics, company policies, rules, procedures and housekeeping standards.
Education / Experience Requirements

More than 10 years hands-on experience in clinical product design.
MSEE, MSME, or MS Biomedical Engineering or equivalent with substantial design experience.
Specialized Skills / Other Requirements

Designed, released, and shipped multiple successful products.
Experience working within a Design Controls/ISO 13485 system or ISO 9001 or similar quality system, or a willingness to rapidly learn these process requirements.
Knowledge of applicable standards and regulations such as IEC 62304, IEC 60601, IEC 62366, and ISO 14971.
Experience with Intellectual Property/Patents desirable.
Strong analytical and problem-solving skills.
Effective verbal and written communication skills.
Team player with good interpersonal skills.
Proficient in Microsoft Office Suite and computerized design applications.

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.