Lead System Designer

Job ID
131722
Job Type
Contract
Industry
Manufacturing
Location
Wauwatosa, Wisconsin, United States

Talascend is currently seeking a Lead System Designer for a REMOTE contract opportunity with our client in the Healthcare industry. 

Overview

The primary responsibility of this role is to serve on the program team to deliver successful and timely NPI and ATD programs. In this role, you will work on AI product development, together with a cross-functional team within Caption and across Ultrasound segments.

Responsibilities

  • Be part of the core program team leading product development programs.
  • Have responsibility to ensure that product programs achieve all design objectives required to meet customer and business needs, including: feature and functionality, quality, reliability, serviceability, manufacture-ability, regulatory, compliance, and cost.
  • Be responsible for driving the end-to-end product development process from requirements capture to V&V and commercial release.
  • Leading the design team and design control process from requirements development, design planning to design transfer.
  • Leading the design team in the development of verification and validation planning and execution for NPIs and released products.
  • Developing requirements flow down, architecture/system design and analysis, risk analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction.
  • Ensure that the quality targets are satisfied and technical risks are addressed as they arise on the program or released product.

Qualifications

  • Bachelors Degree in Computer Science or in STEM Majors (Science, Technology, Engineering and Math)
  • A minimum of 8 years of professional experience in software or medical product development, program management, and/or related field, leading cross functional programs, life-cycle management, and/or large global projects (OR Masters degree with 6 years of experience)
  • 2-4 years experience in project leadership within engineering environment.

Requirements

  • Must be willing to travel as required.
  • Must be U.S. Citizen or Green Card Holder.
  • Demonstrated experience driving requirements development and management and flow-down to subsystems while ensuring traceability between design and test procedures.
  • Demonstrated experience with New Product Introduction (NPI) regulatory compliance process, design history file and related documentation.
  • Experience with AI development would be an added advantage.
  • Strong knowledge of Phase Review Discipline (PRD) and regulatory process for medical device development.
  • Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
  • Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program.
  • Demonstrated ability to balance multiple program priorities while meeting critical commitments.
  • Demonstrated ability to work in a global matrixed organization and deliver results in an ambiguous environment.
  • Excellent influencing, interpersonal and communications skills (both written and verbal) with all levels of an organization; able to build good working relationships.
  • Self-starter - requires minimal direction to accomplish goals, proactive and enthusiastic.

Shift

Day shift, 100% remote, availability from any US time zones.

We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.

Background Check and Drug Screen may be required.

Apply Now

Talascend is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

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