Stronger operations. Measurable results.
Operational excellence, product transfer and interim leadership for regulated manufacturers.
I help medical device, biotech and pharmaceutical manufacturers cut lead times and stockouts, launch and transfer products, and recover from quality setbacks with operations that stay fixed. Based in Massachusetts, working with companies nationwide.
Results from regulated manufacturing
7 → 2 days
Product-line lead time cut from 7 days to 2, well inside a 5-day customer promise.
14 sites
Stockout dollars reduced across a global 14-site manufacturing network.
~$300M
Product revenue fully restored after a multi-SKU regulatory hold tied to a new ISO labeling requirement.
$15M+
~$10M one-time and $5–10M annual revenue recovered through a multi-pathway sterilization remediation program.
What colleagues say
He collaborated exceptionally well across functions, effectively bringing together manufacturing sites and cross-functional teams to address complex and highly challenging situations while thoughtfully balancing compliance requirements with business needs.
Yuan S.
Board Director; former VP, Global Quality
Dan is a great Program Manager who brings the rigor of a Six Sigma Black Belt to his projects and teams. He is a leader who ensures projects are delivered on time, fully compliant, and efficiently.
Ron F.
Director, Operations Engineering
Dan worked tirelessly to resolve any challenges encountered during development of the manufacturing process. Dan was a valuable asset to the project team, a true team player who is always willing to pitch in to help keep the project moving forward.
Teresa N.
Medical Device Project Management Consultant
Consulting services
Operational excellence & Lean Six Sigma
Black Belt-led improvement on lead time, stockouts, yield and variation, using statistical process control and data to fix root causes rather than symptoms.
NPI, product transfer & scale-up
New product introduction, site-to-site and supplier transfers, manufacturing readiness and commercial launch, from development handoff through stable production.
PMO, portfolio governance & interim Chief of Staff
Portfolio prioritization, steering committees, KPIs and CEO-level reporting. Interim operations or Chief of Staff support when leadership needs strategy turned into execution quickly.
Digital manufacturing & practical AI
Connecting digital tools, manufacturing execution and operational KPIs so leaders make better decisions, with AI use cases tied to measurable operating value.
FDA 483 & quality remediation
Recovery programs after FDA 483 observations, product holds or sterilization issues: held-product release, revalidation pathways, external lab and partner coordination, and executive governance that keeps Quality, Regulatory and Commercial moving together.
How an engagement works
1
Assess
A short diagnostic of the problem, the data and the people involved.
2
Plan
Clear pathways, owners, milestones and the business case leadership needs to commit.
3
Execute
Hands-on program leadership with daily management and executive reporting.
4
Hand off
Processes, KPIs and governance your team can sustain without me.
About Dan Ron
I started my career as an actuary and moved into manufacturing through statistical process control, quality engineering and supplier quality, then into senior operations leadership at a global medical device manufacturer. Along the way I have led global NPI portfolios, product transfers, enterprise PMO and governance, and FDA-related remediation programs reporting to the CEO.
That mix of quantitative training and plant-floor operations is what I bring to clients: rigorous analysis, practical recommendations and the cross-functional leadership to deliver them.
- Six Sigma Black Belt
- MBA, Leading and Managing Innovation
- BS, Mathematics / Statistics
- Experience in medical devices, precision machining, electronics and HVAC manufacturing
Frequently asked questions
What does a medical device operations consultant do?
I step into high-stakes operational problems, such as a regulatory hold, a stalled product transfer or chronic stockouts, and lead them to a measurable result while building the systems that prevent a repeat.
Can you help after an FDA 483 or product hold?
Yes. I have led cross-functional recovery programs covering held-product release, sterilization revalidation and executive governance, working alongside Quality, Regulatory and external laboratories.
Do you work outside medical devices?
Yes. Biotech, pharmaceutical and other regulated or precision manufacturers face the same execution challenges, and my background spans several manufacturing sectors.
Do you work remotely or on site?
Both. I am based in Massachusetts and support Boston and New England clients on site, with remote and travel-based engagements across the US.
How are engagements structured?
Typically as a fixed-scope project, an ongoing advisory retainer or an interim leadership role, depending on what the situation needs.
Let’s talk about your operation
Tell me briefly what you’re facing and I’ll reply within one business day, or connect with me on LinkedIn.
