MI
MillerKnollArchitecture and Design Engagement Lead
Design Engagement Lead working with A&D clients to solve problems through creative product design. Leading opportunities validation and telling the story of the Custom Studio.
About the role
- **Key Responsibilities **
- **** System Design and Architecture: **
- Lead the architecture design of medical device systems, ensuring they meet functional, safety, and regulatory requirements.
- The ability to apply a holistic approach ("System of Systems"), as our solution encompasses algorithms and platform next to the device itself.
- Develop detailed system specifications and design documents.
- Ensure the architecture is scalable, maintainable, and adaptable to future requirements.
- Ensure design for manufacturability and cost optimization. Work with manufacturing and procurement to source cost-effective components without compromising on quality and compliance.
- **Technical Leadership: **
- Provide technical guidance and mentorship to engineering team. Act as the technical face of the team.
- Collaborate with cross-functional teams including R&D, QA, regulatory affairs, and manufacturing.
- Stay updated with the latest technological advancements and integrate relevant innovations into the product design.
- **Regulatory Compliance: **
- Ensure all designs comply with relevant medical device regulations and standards (e.g., FDA, ISO 13485, IEC 60601).
- Prepare and review documentation required for regulatory submissions.
- Participate in regulatory audits and assessments as needed.
- **Management: **
- Together with project and product managers develop & own project plans, timelines, and budgets.
- Act in total context (business, markets, customer roadmaps, overall ecosystem), driving for convergence.
Requirements
- **Qualifications: **
- **Education: **
- Bachelor’s or Master’s degree in Electrical, Electronics, Software or Biomedical Engineering, or a related field.
- **Experience: **
- Minimum of 8 years of experience in system architecture and design preferably within the medical device industry.
- Strong expertise in software and electronics, specifically.
- **Proven experience in cost optimization for medical device components and systems. **
- Knowledge of medical device regulations and standards (e.g., FDA, ISO 13485, IEC 60601) is a plus.
- **Skills: **
- Strong analytical and problem-solving skills.
- You combine analytical and architectural thinking, physical insight, flexibility and a hands-on mentality.
- Excellent project management and organizational abilities.
- Effective communication and interpersonal skills.
Benefits
- **What We Offer **
- Opportunity to work on cutting-edge medical device technology.
- Collaborative and innovative work environment.
- Competitive salary and benefits package.
- Technical equipment to set up a home office
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
CO
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