Senior Systems Engineer

PUB376968

About this job

  • Industry: Medical devices
  • Area of expertise: Research & Development
  • Location: Eden Prairie

What is required?

  • Hours per week: 40
  • Education level: Professional Bachelor

About this role: Senior Systems Engineer

** This hybrid position requires applicants to live in Greater Minneapolis/St. Paul, MN **

Our client creates medical devices that give health care providers the insights they need to confidently and safely diagnose patients. For example, if someone you love develops a heart problem, likely the medical team will want to see inside the heart to determine the right treatment. Our client develops devices that tell health care providers what they need to know to be successful for your loved one.

The Senior Systems Engineer position is a key technical leadership role and has responsibility for the design ownership of a single product over the full lifecycle.

In this role, the System Engineer will integrate multi-disciplinary inputs and outputs to support the definition and development of complex software controlled electro-mechanical medical device products. As design owner of a medical device, you are responsible for ensuring that your device is built in accordance with customer, business and regulatory requirements. This is done by effectively translating product requirements to design outputs, managing technical risks of the product, and following the technology roadmap.

This position typically overlaps many technical and human-centered disciplines, including industrial engineering, functional engineering, human factors, security, marketing, regulatory affairs, quality assurance, and project management; a strong candidate will demonstrate a keen ability to facilitate cross-functional collaboration.

The engineer is a key leader in development and management of support activities such as technical planning, systems integration, verification and validation, cost and risk, life-cycle management and effectiveness for total systems.Primary Duties and Responsibilities:
- Ensure the logical and systematic translation of user and project needs into a comprehensive set of system and sub-system requirements in collaboration with the technical design leaders

- Take technical ownership of the product throughout its lifecycle and provide effective technical leadership to the product and engineering teams

- Resolve technical challenges by providing technical guidance to the product and engineering team through rigorous trade-off analysis to create robust and effective solutions

- Facilitate cross-functional technical decision making and optimize the balance between technical and schedule risk with the cost targets of the product lifecycle needs

- Lead the integration of the sub-systems and ensure that the product meets the user and system requirements

- Demonstrate the traceability of requirements through Validation and Verification

- Lead the risk, hazard, and timeline analysis in to quantitatively evaluate design concepts & solutions

- Plan, coordinate, and manage cross-functional design activities and interface directly with the product leadership team on project issues and status

- Integrate sound design principles and standards into your programs including Design for Reliability, Manufacturing, and Service

- Identify user groups, environments, use scenarios and critical tasks for task analysis, instructions, guides, user training and system verification

- Engage with the test teams to ensure plans for verifications and validation activities are successful

- Initiate and lead activities such as Failure Modes and Effects Analysis (FMEA) that identify design issues and lead the team in developing mitigations to address these issues

- Help the team members in developing high-quality documentation for all phases of product development, including design specifications, verification test plans, project schedules, and change orders associated with medical devices

- Partner with the functional technical leaders (Architects/Principals) to develop significant and impactful Intellectual Property to fuel the growth of the business

- Perform work in adherence to the company's Quality Management System (QMS), including development and maintenance of documentation

- Develops products that meet requirements regulated by FDA, EU regulatory body, PMDA, and other governing bodies as defined by product management

- Commit to fostering and driving an environment and work output based on continuous improvement

Requirements

Required:

- Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for U.S.-based job, if not currently employed by company

- Bachelors’ degree in Engineering, or other scientific discipline, preferably electrical, or mechanical

- 7+ years of engineering experience

- 3-5 years new product development and exposure to systems engineering roles

- Demonstrated experience with risk management and systems engineering processes

- Demonstrated ability to clearly and accurately translate needs and requirements

- Ability to grow productive, trusting, and open relationships with a wide variety of constituencies

- Strong interpersonal and communication skills

- High degree of organizational skills and high attention to detail

- Ability to handle multiple tasks and prioritize effectively

- Ability to work both independently and as part of a team

- Ability to develop protocols, conduct system tests and write reports

- Strong initiative and passion about new technologies with high energy

Preferred:

- Graduate degree in Engineering (EE, ME) or another scientific discipline

- 5+ years systems engineering experience

- Experience working with physicians and customers in a medical device product development role

- Working knowledge of tolerance analysis, and geometric tolerance

- Awareness and working knowledge of system-level constraints in all disciplines, including mechanical, electrical and softwareVoice-of-customer experience and Fluency with clinical radiology terminology

Other:- Adheres to all company policies, procedures and business ethics codes and ensures that they are communicated and implemented with the team

- Ability to travel up to 10% of the time

Benefits

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

Join the Brunel Family

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Join the Brunel Family

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

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Any questions remaining?

Your consultant, Kenneth McGreevy is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB376968

Account manager

Kenneth McGreevy
Brunel USA - Boston
k.mcgreevy@brunel.net

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