Systems Engineer III

Description

This position works on projects of medium complexity, or under the guidance of a higher level Systems Engineer on higher complexity projects, and works cross-functionally in the engineering dept.  This position works closely with the engineering technical leaders to provide feedback and updates on Systems Engineering tasks and timelines, resource needs and limitations.  This role ensures that risks are identified and evaluated, discussed, and leads risk documentation.  This role plays a key role in requirements gathering and working cross functionally to define system requirements and specifications.  They also play a vital role in inputting data and maintaining our ALM system where the data will be stored.  This role works with the team to develop and define the system design, architecture and system integration.  They work with the team members to develop test plans for verification and validation.   

This position has the responsibility to lead and participate in UL, EMC, and other regulatory testing as needed.  This position will be responsible during the development of the product for material compliance management and working with the team to obtain and meet REACH, RoHS, etc.

Primary duties include: 

• Provide Systems Engineering technical guidance for projects throughout the phases of research and development, from proof of concept to design and/or to support of new and/or current technologies or products.
• Work with Design and Test Engineers to develop and create test plans for Verifications and Validations to ensure products requirements and specifications are met.
• Understand regulatory guidance to be able to work with teams to ensure proper implementation of design controls, including risk management, design verification, and validation activities.
• Design history file creation: Support generation of design history files (DHF) to document the design and development process, ensuring compliance with regulatory standards. Organize and compile relevant design documentation, including design inputs, outputs, verification, and validation records.
• Collaborate with cross-functional teams both business and technical partners: Work closely with cross-functional teams, including design engineers, quality engineers, regulatory specialists, and manufacturing teams, to foster collaboration and ensure effective communication throughout the product development lifecycle.

Additional information about this position:

• Works on medium complexity projects.
• Generally, works on a team with other engineers.
• Receives moderate oversight from a Senior Systems Engineer.
• Travel <5%
• Must wear PPE throughout the day 

Minimum Qualifications: 

Education & Experience: 

• Bachelor's Degree in Engineering
• 5 year's experience in an engineering role

Knowledge, Skills, Abilities: 

• Solid experience in the medical device industry, specifically in research and development.
• Strong knowledge of product development processes and methodologies.
• Excellent analytical and problem-solving skills.
• Ability to develop clear and concise reports.
• Experience in creating design verification plans, test cases, and conducting testing.
• Familiarity with reliability test planning and execution.
• Understanding of design controls and regulatory requirements.
• Ability to create and maintain design history files (DHF).
• Strong interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams.
• Familiarity with regulatory requirements and quality management systems in the medical device industry.

 #LI-US

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at recruitment@biomerieux.com.

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).