Medical device manufacturing partner is seeking a Systems Engineer to join the team.

POSITION OBJECTIVE:

Leads and participates in the design and development of medical devices for interventional radiology and vascular surgery, which includes new products and line extensions. Assumes complete responsibility for the system level activities to ensure product architecture meets the user needs and the design meets the required standards and has regulatory compliance.

PRIMARY RESPONSIBILITIES:

1.Take ownership of the systems engineering activities on new product development projects, by creating product architecture, System requirements, Product specifications from clinical requirements and user needs. Must be familiar with the System Life Cycle Process per ISO/IEC/IEEE 15288:2015

2. Collaborate with cross-functional teams to ensure all development activities are conducted in adherence to applicable standards and regulations, guidelines, company policies, SOPs, and industry standards.

3.Participate as an active member on product development teams to ensure completeness of the design history file., Support regulatory submissions, including creation, review, and management of technical documents. Maintain traceability, risk management, FMEAs, Hazard Analysis, etc

4.Manage the execution of specific engineering deliverables (engineering study reports, manufacturing instructions, system level tolerance stack analysis, packaging guidelines) associated with the launch of new products, with close coordination with the manufacturing engineering teams

5.Guide validations and verifications team with system verification plans, protocols, and assist with the execution of verification tests as a SME

6.Execute human factors studies, assist formative and clinical studies as required by working closely with the clinical engineering staff

7.Any other duties that may be assigned based on the product development requirement.

SKILLS & ABILITIES:

*Demonstrated expertise with development of medical devices for interventional radiology, vascular surgery and minimally invasive procedures.

*Proficiency in SolidWorks, Data analysis and interpretation, GD &T

*Critical thinker who exhibits creativity and innovation

*Project Management Experience is desirable but not a requirement

*Experience with applicable standards and regulations is an added advantage

*Minimum of 10 years' experience in system engineering, of which at least 5 years in medical device industry

REQUIRED QUALIFICATIONS (EDUCATION AND EXPERIENCE):

*Bachelor's degree in Bio-Medical Engineering or Mechanical Engineering (No EXCEPTIONS)

*10 years of total related experience

SPECIAL REQUIREMENTS:

*While performing the duties of this job, the employee is frequently required to talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is regularly required to stand, walk, and/or sit and may occasionally be required to reach above shoulders, climb, stoop, kneel, crouch or crawl.

*The employee must occasionally lift and/or move up to 10 pounds while moving paper work or educational materials. The employee must occasionally lift or move up to 50 pounds.Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.