Call Summaries

Unilever

Process Engineer

Colin worked in a sustain role on a variety of lines. His primary responsibilities included monitoring via Epicor Informance, taking on downtime/quality based projects. Biggest challenge is the tribal nature of knowledge - e.g. as a new engineer fixing a piece of equipment like a cartoner. Unilever likely has ~100 process engineers in NA.

- Tribal knowledge base for past information on equipment issues/work.

Roam Robotics Ford

NPI Mechanical Engineer Design and Release Engineer

Nate wears many hats as Roam is a startup. Manufacturing at Roam is straightforward as it is mostly last-mile assembly. This conversation mostly focused on contract manufacturing. At Roam, they have experienced supplier quality issues e.g. not getting the requested amount of pressing power or not getting plastic that is truly “medical grade”. At Ford, negotiating a part agreement with a supplier can be a 2-3 month milestone.

- Inefficiencies in the vendor verification and negotiation process.

Honeywell

Project Engineering

Leah’s roles span ceramics products, value engineering, and supplier quality. Ceramics will have 3-4 manufacturing engineers on the line, tuning during NPI to ensure tolerance thresholds are met. Honeywell has custom internal infrastructure for managing vendor relations and qualification.

Mainstream Fluid & Air Sequoia Applied Solutions

Project Management CNC Programmer

At Sequoia, Spencer was the primary CNC programmer. He encountered difficulties writing G-Code as a remote employee because choosing feeds/speeds is often a dial-in iterative process. At MF&A, the primary problem they encounter is the good vendors being fully booked up, and the bad vendors missing quality checks. Estimates they will have issues with ~13% of their contract jobs.

- Supporting remote G-Code programming during feed/speed tuning. - Vendor quality.

Dupont

Field Engineer

Andie’s primary responsibilities on a film production line are product monitoring (quality/production), guiding line operators, and taking on small scale capital projects like equipment replacement/upgrade.

- Navigating capital project process.

Honeywell

Process Development Engineer

Blake worked on a major NPI for ceramics coatings at Honeywell in a team of ~8 PEs. The most painful part of this was the iterative process of tuning coating parameters to meet the tolerance requirements - iterations require re-running parts. Blake also raised issue from his new role in supply chain - though the data is available, complex cross-site manufacturing processes often get inefficiently ordered, resulting in missed deadlines, due to lack of alerting/visibility on production schedules + timing.

- Iterative tuning process for coatings. - Missing deadlines due to poor intra- and cross-site coordination for complex manufacturing.

SC Johnson

Process Engineer

Carmen was responsible for plant data monitoring, equipment replacement/upgrade, NPI, and writing operator procedures.

- Learning curve for equipment selection, e.g. knowing the right pump to pick.

Ford

Powertrain Production Planning

Matt’s role is combining demand forecast and capacity data to define the production plan.

Pratt & Whitney

Manufacturing Engineer

In his first role, Jake’s responsibilities included monitoring, involved engineering change projects (e.g. automation), and resolving quality issues. He’ll use Siemen’s PlantSimulate to do detailed digital twinning of the line for his projects.

- Monitoring data collection can be contrived - e.g. machine writes .txt file, saves to folder, old custom VBA script serves as connector.

Honeywell

Project Engineer

Everett is mostly focused on the research phase of electrical propulsion at Honeywell. His role involves a lot of mediation between deep engineering folks and manufacturing/supply chain people.

- Can be difficult to locate suppliers meeting requirements, e.g. FAA-compliant gearbox.

P2R Tartan

Appraiser

Bryan is a generalist working on equipment appraisal for manufacturing liquidations and on machining. Discussed “fine” vs. “coarse” manufacturing, and how the number of MEs/PEs scales with manufacturing complexity.

- “Competency Crisis”, finding talent for operating CNC machines to meet demand.

QinetIQ

Systems Engineer

Adam works on undisclosed projects involving analog circuitry. A lot of his work is going back and forth with customer on meeting/modifying circuit specifications. Mentioned part digital twin concept - where company keeps a registry of all parts they ship, combine that with sensor data, and send the customer maintenance notifications.

Yanfeng

Director, Seat Engineering NA

- Denise is in a cross-functional role that involves working with AMEs for new product introductions at Yanfeng. - AMEs write documents and configure the line. - Configuration can be modeling/parameter intensive e.g. injection molding, or more manual like welding step. - IT department handles monitoring. - Biggest hurt for AMEs is paperwork - PFMEA, ODS. - 50-100 AMEs in NA.

- Dealing with paperwork.

Tesla

Manufacturing Engineer

- Ford role not that interesting. - Tesla manufacturing engineers focus on NPI. - Process development engineer will handle step preparation, equipment validation, quality validation, and hitting KPIs (cycle time, yield, availability). Then pass to production engineering. - PFMEA documents will take 20 hours of time. - Late PFMEA requirements that vendor refuses to handle are the most painful thing. Triggers expensive and understaffed internal process for updating equipment.

- Bad order of operations on PFMEA results in expensive internal equipment modifications.

Pfizer Merck

Project Manager, New Products

Olivia worked in quality for finished vaccines coming off the manufacturing line at Merck. Will help with introductions.

Unilever

Process Engineer

- Process engineers at Unilever explicitly do not handle plant innovation, that is a separate team. - PEs take smaller projects like digitalization of approval workflows. - Monitoring is 20-25% of the work.

Tesla Boston Scientific

Manufacturing Engineer

- Most painful thing at Tesla is the timeline, everything is moving very quickly. - Lauren cannot confirm PFMEA issue mentioned by Daniel Whitford but hasn’t hit that point in process yet (she’s new). - Most painful thing at Boston Scientific is inheriting poor processes. E.g. tasked with fixing crappy injection molding process in first role, then moving inefficient manufacturing line is second. “Not being set up for success.” - 300-500 MEs in NA for Boston Scientific. - Prefer to contract parts, but many small/complex injection molds will not be taken on by suppliers and are done in-house.

DENSO

Process Engineer

- Olga works in a team of 5 PEs supporting automotive condenser production. - Olga has a combination sustain/NPI role. - The thing that hurts the most is DENSO’s internally developed PFMEA management system (”Nexus”). Literally crashes, is slow - can waste 3-4 hours of her time in a day. - Olga does not write any code, on site EE does that. - Olga does not spend much time on monitoring, 3-5%. - Most of Olga’s time is NPI and continuous improvement projects.

- Bad PFMEA software.

Honeywell

Manufacturing Engineer

Work was mostly inspecting physical defects.

Merck

Specialist, Engineering

- Global NPI line setups at Merck. Everything from working with the architectural consulting firm to build the building, all the way to setting temperature parameters on the line machines for the production line. - Works mostly on drug product equipment like filling syringes, tubs, etc. - Most painful part of the process for her is automation testing cycles. E.g. automation team has a much more extensive suite of validation, and she will be blocked for 2 weeks waiting on them to finish testing, then have to REDO her test. She is generally in critical path so delays for her are delays of overall product timelines. - Mentioned additional issue about people not liking the digital paperwork system they are using (Kneat). Software not smart enough to allow for small changes without FDA exception (e.g. wrong door label in test, etc.). - They use DeltaV (Emerson) as their line control system at Merck.

- Long controls testing cycles.

Merck

Specialist, Engineering

- Akshath works in a deviation management unit for biologics. The types of deviations he deals with are generally cross-functional, e.g. post-process date labeling not meeting China requirements, mislabeled product, etc. - 75% of his role is responding to issues, 25% is CI projects. - Most of the issues he deals with are people issues, e.g. operator not doing the right thing. Corrective actions frequently involve training. - Akshath not directly in the role we are investigating but seems very helpful and willing to make intros.

Northrop

Manufacturing Engineer

- Works on high-mix, low volume manufacturing, circuit boards for defense/space projects in Virginia. - Individual components will cost between $100,000-$500,000. - Does a mix of design/sustain, qualified 20-30 new designs in the last year with 80-150 steps per design. - Example task he would do is configuring a soldering machine. - Most painful area is debugging issues, but would not go into a specific example of debugging due to confidentiality. - Followed up with an additional issue over text, mentioning that a system to track incoming parts and connecting them to vendors to track quality would be useful. Incoming part traceability is poor which gives them little insight into vendor performance.

- Vendor quality management.

Intuitive

Manufacturing Engineer

- George works on optical manufacturing for the display component of the surgical robots. - Most painful thing is debugging downtime issues - e.g. working with small parts and the parts fall into the machine, or don’t have the camera at the right place, etc..

Intuitive

Manufacturing Engineer

- Austin is a tenured ME at Intuitive, experience in robotics systems for medical devices as well as parts like catheters. - PFMEAs in medical device context don’t generally add requirements onto vendor like they do at Tesla, generally “take machine as you get it”. - 50% of job on NPI is doing qualification, including writing and in-process monitoring. High-risk processes are the worst because the qualification process is really long. - < 10% of job on monitoring in his business unit. His peers “want NOTHING to do with this”. - In catheter role, was responsible for moving production lines. - Very long discussion on constructing traveler/BOM during production line movement, issues they have with part scaling.

- Bad ERP setup makes line “copy-and-paste” very difficult.

Tesla

Manufacturing Engineer

- Mitch is a tenured ME at Tesla who has worked his way through sustain, NPI, and into a pilot plant role. - Covers everything in powertrain assembly and machining. - Mitch’s biggest problem is communication between design and ME. - Long discussion on revision control - both on design files (e.g. CAD) and on machine configurations for the plant. Mitch is working internally to introduce some version control system to his group. - Mitch gave confirmation on PFMEA inversion issue seen with other Tesla engineers, but his analysis and potential solution does not indicate much promise for fix.

- Version control on automation configurations.

Medtronic

Manufacturing Engineer

Claire works in a sustaining position on a line that makes batteries for implantable defibrillators. Her responsibilities are handling issues on the line, and taking on improvement projects to make processes more lean by e.g. reducing scrap.

- Balancing optimizations. E.g., if reducing scrap in one part of the line decreases yield in a downstream process, it’s not worth doing. Can be difficult to detect these cases.

Stryker

Manufacturing Engineer

Grant works on the assembly line for the Mako surgical robot. His responsibilities are examining defect supplier components, diagnosing issues with robot/robot subcomponents. Diagnosing failures is normally easy. What’s difficult for optimization processes is collecting the data.

- Manual data collections supporting optimization projects can take a long time.

DENSO

Process Engineer

Val works on a condenser assembly line. 50% of his time is handling machine downtime on the line, 50% is taking on improvement projects.

- Adjustments (incl. manual) to machines are not always recorded, resulting in silent hard-to-find issues. - Collected downtime events are not very accurate. Often they rely on manual operator notes, but an operator running parts with a quota is not very incentivized to be detailed. - Quick replacement parts for machines. E.g. if a critical component goes down, they’ll pay 4x usual cost to get shipped immediately.

NuVasive

Manufacturing Engineer

Chaitanya is a senior engineer who has had roles doing NPI, line moves, and sustaining.

- Tuning parameters for proprietary internal process that is lacking simulation software is difficult. Requires running 50-100 samples.

Ford

Executive Director

Adrian is a long-tenured member of Ford in charge of their global manufacturing organization. Ford is working closely with Siemens to get all work end-to-end in a digital environment. Adrian raised doubts as to whether people would be willing to pay for problems we are exploring - recommends focusing on post-NPI optimization answering question “How can we get more units?”

Siemens Healthineers

Manufacturing Engineer

Michael is an ME primarily focused on injection molding processes. A big chunk of his current work is on-shoring injection molding processes from China. Most painful thing is recreating these processes using incomplete information - oftentimes the documentation he gets from Chinese producers is poor, if it is available at all.

- Injection molding vendors do not provide sufficient information on their process for SHE to reproduce them easily.

Medtronic

Manufacturing Engineer

Devin is a ME primarily focused on sustaining a plastic extrusion line. The most painful thing for him is diagnosing issues without knowledgeable operator assistance - e.g. the operator who could fix it right away works 3rd shift.

- Availability of tribal knowledge for the line.

Rivian Canoo Tesla

Manufacturing Engineer

Daniel is a ME primarily focused on tool/die making. At Tesla, he worked on the leading edge of design for manufacturing, making sure that the parts would be manufacturable during production ramp-up. Had similar roles at Canoo/Rivian.

- Product lifecycle management issues. E.g., was difficult to manage at Tesla before “Jira got good”.

NuVasive

Manufacturing Engineer

Justin is deeply focused on the complex additive manufacturing process used for NuVasive’s titanium implants.

- Feedback loop on iterations is slow, complex parts can have ~100 iterations. They only get one print a week in usually, and can do 6 iterations in one print.

Rivian

Manufacturing Engineer

Mario and I walked through a few specific problem areas - design for manufacturing collaboration, configuring automation systems, and general process automation.

- Hardest part of DFM is just communicating with the various stakeholders involved over email. - Hard part of process optimization is ensuring the plan you create does not violate ergonomic requirements (e.g. lift > 30 lb without lift assist).

Boston Scientific

Project Manager R&D

Drew and I spoke mostly about the design for manufacturing process at Boston Scientific. Drew sees no issue with the tools they have in this process, but recommended raising the question to the tech team responsible for these tools as they would have more insight across the organization.