Sr. Systems Manager

Job Description

The Senior Systems Manager will drive medical device system development efforts at Access Vascular Inc. This role involves direct supervisory responsibilities, as well as technical contributions on 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 with phase-appropriate efforts.

Duties and Responsibilities

This may include but is not limited to the following:

• Design & Development: Drive the design and development of a medical device with electrical, software and mechanical features. Design and development around signal acquisition, analysis, and presentation to the user via GUI is of particular focus.
• Project Management: Work with PMO to 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 effort, and plan with an eye to design transfer where close collaboration with Supply Chain and Operations is critical.
• 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 SOPs and work instructions to support expansion of AVI’s core technology to medical device systems with an emphasis on software development and cyber security. 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 Transfer: Support manufacturing transfer efforts from Design and Development to manufacturing, including management of contract manufacturers for prototype as well as higher scale quantity builds (including packaging).
• Design Improvements and Sustaining: Analyze data for conformance to design specifications and recommend and implement design improvements to product platforms including components required for vascular catheter insertion procedures.
• 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: 15+ 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.
• Management: This individual may supervise engineers, engineering support/technicians and/or co-ops.
• 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, ISO 62304 and 62366, IEC 60601, ISO  10993, FDA QSR).
• Software Skills: Proficient with Microsoft Office Software products, including MS Project.