Sr. Director of Engineering

Job Summary

We are seeking a dynamic and innovative Senior Director of Research & Development with extensive experience in medical device development to lead our Microtek & OEM R&D team. Our Microtek & OEM business includes some of the leading operating room draping solutions in the industry, including:
• OEM Portfolio (focus): We design, commercialize and manufacture custom surgical draping and kitting solutions for some of the largest medical device manufacturers in the world.
• Branded Portfolio: The Microtek branded portfolio includes industry-leading probe covers and equipment drapes, fluid warming and slush drapes, patient drapes and other operating room solutions.

This role will lead efforts across multiple R&D teams, including Technical Project Management (Project Managers), New Product Introduction (NPI) Design & Development (Biomedical Engineers), Verification & Validation (Test Engineers) and Post-Launch Engineering (Lifecycle Engineers).

The ideal candidate will be a strategic leader and bring a proven track record of driving innovation, managing cross-functional global teams, and ensuring compliance with regulatory standards (such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971). This role will play a pivotal part in delivering user-centered designs and maintaining our position as a leader in the medical device industry. You will have the chance to directly influence organizational growth, develop life-changing products, and work in a collaborative environment where your expertise and leadership will make a lasting impact.

Medline is a fast-paced healthcare and supply chain leader, so being comfortable leading with agility and partnering across central corporate resources is vital for efficiency. Our key offices are in Alpharetta, GA (engineering & labs), Eagan, MN (customer-centric advanced design center), the Dominican Republic (2 manufacturing sites) and Northfield, IL (Medline headquarters). The ideal candidate be based out of either Alpharetta, GA (preferred) or Minneapolis, MN, while being committed to travel 1-2 weeks a month to the other sites for key collaborative meetings & development reviews.

Job Description

Leadership & Strategy:

• Lead and mentor a global 30+ associate R&D team, fostering collaboration across regions to ensure high performance, retention, and engagement.

• Develop and implement strategic plans to drive innovation and accelerate growth while meeting business objectives.

• Manage R&D initiatives across multiple locations and oversee project portfolio exceeding $200M in value.

• Serve as the R&D representative in due diligence for mergers and acquisitions, ensuring smooth integration and post-acquisition performance.

Innovation & Product Development:

• Direct the end-to-end product development process, from ideation to commercialization, ensuring timely delivery within budget and regulatory requirements.

• Leverage user-centered design principles to develop innovative solutions that meet customer needs and achieve business goals.

• Drive the implementation of new usability engineering strategies, including front-end innovation, simulation labs, and customer insights translation.

• Manage intellectual property development, including patent filings and technology scouting.

Regulatory Compliance & Quality Management:

• Ensure all products comply with FDA regulations, ISO 13485, ISO 14971, and 21 CFR Part 820 standards.

• Implement and oversee robust design control, risk management, and quality system processes.

• Collaborate with quality and regulatory teams to improve training compliance, product traceability, and adherence to industry standards.

• Manage audits and regulatory inspections to maintain compliance and readiness.

Financial & Operational Oversight:

• Manage multi-million-dollar R&D budgets with a high degree of accuracy, ensuring optimal resource allocation.

• Identify and execute cost-saving opportunities, including process improvements and supplier partnerships.

• Oversee the qualification of new manufacturing partners and production sites in compliance with regulatory and quality standards.

Cross-functional Collaboration:

• Partner with supply chain, marketing, and business development teams to deliver high-impact product solutions.

• Lead and facilitate innovation reviews with executive leadership to align R&D priorities with organizational goals.

• Serve as the site leader for a cross-functional team, ensuring alignment on safety, culture, and operational excellence.