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SYSTEMS ENGINEER II


At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 

Job Overview

As a Systems Engineer, you will utilize your engineering and research skills to create, manage, analyze, and maintain the DHF, product risk management files (risk planning, risk analysis, risk mitigation, and verification of risk control implementation/effectiveness), and associated documents. In compliance with governing procedures, 21CFR 820.30 Design Control, CFR Part 4 Combination Products, and ISO 14971, you will help support product development and submission activities.

 

-    Provide technical support in the development of the Design History File for Combination Products including global regulatory filings, DHFs, risk management, and design controls
-    Research device clinical use, standards, and other relevant regulatory guidance for DHF content generation in support of regulatory submissions with compliance to governing procedures, 21CFR 820.30 Design Control, CFR Part 4 Combination Products, and Risk Management per ISO 14971 for the device constituent and drug-device interfaces of combination products.
-    Research industry best practices and define state-of-the-art
-    Analyze comparable product complaints history and standards for product requirements to create robust design requirements ensuring user needs are met
-    Partner with other functions including manufacturing, Safety/Clinical, Human Factors and Design Engineering to develop FMEAs ensuring root causes and errors are identified & mitigated; provide support to risk management activities; provide risk and systems engineering input to cross functional teams and to instill a spirit of collaboration throughout the organization.
-    Supports Combination Product inspection readiness and regulatory responses as needed.
-    Participate in focus groups in early use case development to identify unmet needs for design & engineering concept development.
-    Support the completion of gap assessments against industry regulations or standards
-    Extract and summarize scientific information from internal studies to identify details required for regulatory submissions, regulatory responses, inspection readiness.
-    Author technically simple and complex documentation to ensure technical competence to relevant local and federal regulations by working closely with various departments including Systems, Risk Management, Safety, Clinical, Human Factors, and Design Engineering.
-    Performs other related duties as assigned. 
 

What your background should look like:

-    Bachelor's degree in engineering, physical sciences, or technical writing with 5+ years of experience.
-    Experience in risk management and design control of medical devices or combination products from concept through launch.
-    Basic understanding of engineering principles, system design, and risk management
-    Experienced with performing risk assessments using a variety of tools (e.g. FMEA, FTA, HACCP, etc.)
-    Broad technical knowledge related to the design/operation of drug combination product platforms, design control, risk management, ISO 14971/24971, and 21 CFR 820.
-    Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues
-    Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement
-    Proven ability to succeed in a fast-paced, challenging, and complex environment.

Competencies

Values: Integrity, Accountability,Teamwork, Innovation

About TE Connectivity

TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With more than 85,000 employees, including over 8,000 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.

What TE Connectivity offers:
We offer competitive total rewards compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive and will meet the needs of our associates.

  • Generous 401(k) Plan
  • Tuition Reimbursement
  • Benefits start on day one
  • Charity Donation Matching Program
  • Competitive Paid Time Off
  • Employee Resource Groups
  • Employee Stock Purchase Program
  • Healthcare for Associates and Families
  • Health and Wellness Incentives
  • Life Insurance and Disability Protection

Throughout our Global reach and various Business Units, we take a balanced approach to the benefits we provide. Many benefits are company-paid, while others are available through associate contribution. Specific benefit offerings can vary by location.

 

EOE, Including Disability/Vets

Location: 

Plymouth, MN, US, 55442

City:  Plymouth
State:  MN
Country/Region:  US
Travel:  Less than 10%
Requisition ID:  89535
Alternative Locations: 
Function:  Engineering & Technology


Nearest Major Market: Minneapolis

Job Segment: Compliance, Systems Engineer, Technical Writer, Inspector, Manufacturing Engineer, Legal, Engineering, Technology, Quality

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