Biotech Process Engineer Jobs in Madison, WI (NOW HIRING)

JOB OBJECTIVE: Design and develop the physical hardware for connected IoT devices that enable intelligent, real-time solutions in healthcare and other markets as needed. Focus on delivering robust, manufacturable, and regulatory-compliant hardware products while partnering across disciplines to ensure seamless system integration within IoT environments.
As market demands evolve, this role may contribute to the development of medical devices, requiring alignment with FDA and international regulatory standards. Implement emerging tools and practices, including AI and automation.
CORE DUTIES:
1. Participate in the mechanical and electromechanical design of IoT devices from concept through production, with a focus on performance, reliability, and integration.
2. Develop detailed engineering documentation, including CAD models, wiring schematics, BOMs, build protocols, and quality control records.
3. Plan and execute hands-on hardware prototyping, fabrication, iterative testing, and validation aligned with product and regulatory requirements to meet product development timelines.
4. Conduct design iterations, optimization and risk mitigation activities, including Design for Manufacturing, Assembly, Test, etc.
5. Plan, author, conduct, and document testing and experiments to verify design assumptions, performance, and safety compliance.
6. Support hardware integration with cloud and connectivity modules through design and physical layout considerations.
7. Assist with hardware certification and compliance processes for global standards such as FCC, CE, ISO, and potentially FDA 21 CFR Part 820 or ISO 13485 for future medical devices.
8. Collaborate with other colleagues, firmware, QA teams to ensure seamless hardware-firmware integration.
9. Work with wider cross-functional teams to address quality, manufacturability, supportability, and production scaling issues.
10. Manage project deliverables and milestones, while clearly communicating status, risks, and technical findings to leadership and team stakeholders.
11. Contribute to risk management and traceability documentation aligned with medical device lifecycle standards where applicable.
12. Maintain organized records of design revisions, test outcomes, and lessons learned for knowledge sharing and regulatory traceability.
13. Evaluate and implement new engineering tools and practices, including test and fabrication equipment, design simulation, AI and automation technologies, for future integration.
14. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity, and respect for others.
15. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work.
16. Understands and complies with ethical, legal, and regulatory requirements applicable to our business.
KEY QUALIFICATIONS:
1. Bachelor's or degree in Mechanical Engineering, Product Design, or a related field.
2. 5+ years of related product design experience, preferably in IoT hardware or medical device environments.
3. Strong proficiency in modeling software (SolidWorks) for creating models, assemblies, and drawings and supporting production.
4. Experience performing engineering analyses, testing, and troubleshooting for mechanical and electromechanical systems.
5. Understanding of electromechanical system design and how mechanical interfaces affect electronics, sensors, and antenna performance.
6. Familiarity with design-for-manufacturing best practices and component sourcing.
7. Awareness of regulatory expectations for product development in highly regulated markets (e.g., FDA, ISO 13485) with a willingness to adopt compliant practices.
8. Communicate effectively with internal teams, vendors, and external stakeholders.
9. Clear communication skills and ability to collaborate across engineering disciplines.
PREFERRED QUALIFICATIONS:
1. Experience in regulated industries such as medical devices, diagnostics, or biotech.
2. Experience designing products from initial concept phase through installation and support.
3. Understanding of certification and compliance standards such as ISO13485, IEC60601, FCC, or CE.
4. Experience analyzing engineering test data to generate clear, accurate reports that support product validation and performance assessment.
5. Familiarity with design history files (DHF), device master records (DMR), and other medical device documentation processes as required by Quality Management System (QMS).
6. Interest in future integration of automation or AI-enhanced tools in engineering workflows.
PHYSICAL DEMANDS:
1. Extensive use of hand and power tools to assemble proof of concepts and prototypes
2. Occasionally move large equipment or hardware related to testing or development activities.
3. Ability to remain stationary for extended periods while working at a computer or engineering bench.
4. Ability to work safely around electrical equipment, mechanical systems, or testing setups.
At Terso, we are committed to building a diverse workforce that reflects the communities we serve and creating a culture where everyone belongs. As an Equal Opportunity Employer, we welcome and encourage applications from all backgrounds, ensuring that employment decisions are made fairly and equitably.