Systems Engineer – Medical Devices

Novozen Healthcare LLC; Minnesota; Presencial; USD 52 000 - 54 000; Tempo parcial

Resumo da oferta

Novozen Healthcare LLC in Plymouth, Minnesota seeks a Systems Engineer to support medical devices across development and lifecycle stages. The role emphasizes translating user needs into system requirements, maintaining traceability, and ensuring V&V and DHF compliance.

The ideal candidate has 3+ years in a regulated environment, strong electromechanical/software systems knowledge, and familiarity with requirements management, risk management, and design controls in a healthcare setting.

Qualificações

• Bachelor's or Master's degree in Electrical, Software, Mechanical, Biomedical Engineering, or a related field.
• Minimum 3 years of relevant engineering experience.
• Strong systems engineering background involving electromechanical and software-based systems.
• Experience with regulated medical devices or other highly regulated products (e.g., aerospace, automotive, or military).
• Experience with requirements management, risk management, system integration, verification, and validation (V&V).
• Knowledge of connected and software-enabled devices and cybersecurity is preferred.
• Familiarity with SysML/UML and requirements management tools.

Responsabilidades

• Support systems engineering activities across new product development and product lifecycle management.
• Translate clinical and user needs into system requirements and maintain requirements traceability.
• Develop design concepts and system architectures, and support system integration, verification, and validation (V&V).
• Maintain Design History Files (DHF) and product risk management documentation.
• Conduct impact assessments for design, material, process, manufacturing, and field changes.
• Identify technical risks, troubleshoot system issues, and develop effective mitigation strategies.
• Collaborate cross-functionally with Software, Electrical, Mechanical, Quality, Regulatory, Manufacturing, and Service teams.
• Ensure compliance with FDA regulations, ISO and IEC standards, and medical device design control requirements.

Formação académica

Bachelor's or Master's degree in Electrical, Software, Mechanical, Biomedical Engineering, or a related field

Descrição da oferta de emprego

Job Title: Systems Engineer – Medical Devices

Location: Plymouth, Minnesota

Employment Type: Contract (12 Months)

Job Responsibilities:

• Support systems engineering activities across new product development and product lifecycle management.
• Translate clinical and user needs into system requirements and maintain requirements traceability.
• Develop design concepts and system architectures, and support system integration, verification, and validation (V&V).
• Maintain Design History Files (DHF) and product risk management documentation.
• Conduct impact assessments for design, material, process, manufacturing, and field changes.
• Identify technical risks, troubleshoot system issues, and develop effective mitigation strategies.
• Collaborate cross-functionally with Software, Electrical, Mechanical, Quality, Regulatory, Manufacturing, and Service teams.
• Ensure compliance with FDA regulations, ISO and IEC standards, and medical device design control requirements.

Required Qualifications:

• Bachelor's or Master's degree in Electrical, Software, Mechanical, Biomedical Engineering, or a related field.
• Minimum 3 years of relevant engineering experience.
• Strong systems engineering background involving electromechanical and software-based systems.
• Experience developing medical devices or other highly regulated products, such as aerospace, automotive, or military systems.
• Experience with requirements management, risk management, system integration, verification, and validation (V&V).
• Knowledge of connected and software-enabled devices and cybersecurity is preferred.
• Familiarity with SysML/UML and requirements management tools.

Preferred Qualifications:

• Experience with requirements management tools such as DOORS and Jama.
• Familiarity with Teamcenter, TrackWise 8, JIRA, and ALM.
• Medical device experience, particularly in ICU, kidney care, continuous renal replacement therapy (CRRT), or acute therapies.
• Experience with Design of Experiments (DOE), statistical methods, and verification testing.
• Strong analytical, problem-solving, communication, and stakeholder management skills.

Ideal Candidate:

A Systems Engineer with 3+ years of experience in medical devices or another regulated industry, strong knowledge of electromechanical and software-based systems, and hands-on experience with requirements management, risk management, Design History Files (DHF), system integration, verification and validation (V&V), and design controls.

Pay Scale

Anticipated hourly pay rate: specific range such as ($38/hr to $39/hr) - DOE.

Benefits

Employees hired into this position may be eligible for benefits, subject to applicable plan terms and eligibility requirements:

• Health Insurance: Medical, dental, and vision insurance options may be available through a third-party provider. Employees may be responsible for some or all of their insurance premiums, depending on the applicable plan.
• Retirement Benefits: A 401(k) retirement savings plan may be available, subject to plan eligibility and applicable terms.
• Paid Time Off (PTO): PTO eligibility is subject to the applicable employment agreement and state and local requirements.