Job Title: Systems Engineer
Location: Plymouth, MN
Duration: 12 Months
Job Description:
We are seeking a Systems Engineer to support medical device product development and lifecycle management. The role will focus on requirements management, system integration, risk management, design controls, verification, and validation.
Key Responsibilities:
- Support systems engineering activities across new product development and product lifecycle management.
- Translate user, clinical, regulatory, quality, manufacturing, and technical needs into system requirements.
- Develop and maintain requirements, traceability, risk management, and DHF documentation.
- Support system integration, verification, and validation activities.
- Identify technical risks, perform impact assessments, and develop mitigation strategies.
- Troubleshoot complex system-level issues using structured problem-solving and root-cause analysis.
- Collaborate with cross-functional teams including Engineering, Quality, Regulatory, Manufacturing, Software, and Human Factors.
- Ensure compliance with applicable FDA, ISO, and IEC requirements and design controls.
- Manage multiple priorities and deliver technical solutions within project timelines.
Required Qualifications:
- Bachelor's or Master's degree in Electrical, Software, Mechanical, Biomedical Engineering, or related discipline.
- 3+ years of relevant experience in systems engineering or product development.
- Medical device or other regulated-industry experience preferred.
- Experience with electro-mechanical systems, software-enabled products, and/or connected devices.
- Knowledge of SysML/UML and requirements management tools.
- Experience with DOORS or Jama preferred.
- Familiarity with Teamcenter, TrackWise, JIRA, or ALM preferred.
- Knowledge of risk management, design controls, DOE, and statistical methods.
- Strong analytical, problem-solving, communication, and cross-functional collaboration skills.
- Ability to manage multiple projects and changing priorities.
Benefits:
Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.
Equal Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.