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Sr. Systems Engineer

3 months ago

Billerica, United States Access Vascular Full time
Job DescriptionJob Description

The Senior Systems Engineer will spearhead the development of new product development efforts at Access Vascular Inc. 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 Responsibilities

This 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/Competencies
  • Educational 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.
  • Technical Proficiency: Proficient in the design of systems with mechanical, electrical, and software elements. Capable of creative problem solving, quick comprehension, and skeptical analysis.
  • Communication: Excellent communication skills to support working independently and within a team. Efficient and effective communicator, both verbally and in writing.
  • Regulatory Knowledge: Intimate knowledge of applicable standards (e.g., ISO 13485, ISO 14971, FDA QSR).
  • Customer Service: Strong, passionate understanding of and commitment to customer service.
  • Software Skills: Proficient with Microsoft Office Software products, including MS Project.

About Access Vascular

Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .