handbook

What Matters to Us

Enzyme was started to help companies get cutting edge, quality technology to patients faster. We strive to facilitate this for our customers by providing best-in-class information and tooling.

Why Enzyme?

After spending a decade each in the medical device industry, our founders Jared and Jacob grew exhausted with the status quo day-to-day Quality Management System (QMS) activities and submission generation.

Jacob used a plethora of QMS software tools for routine tasks (i.e. different tools for the varied elements of a QMS), and many users either 1) had partial/no access to all systems or 2) had significant difficulty using many systems due to infrequent access. This resulted in delays to getting work done amounting to weeks or months for a single project and ultimately to millions of work-hours per year across an enterprise. Enzyme combines and integrates workflows to significantly reduce the work-hours necessary to accomplish project objectives.

Jared co-founded a consulting firm before Enzyme that specifically aided companies in submission generation. While doing that, he learned of the immense waste of resources that companies invested in submission writing.

Both Jared and Jacob share a vision of a unifying QMS tool that streamlines numerous workflows and assists in document creation through auto-generation via Machine Learning & Natural Language Processing features.

Too often good product ideas fail to commercialize due to what seems to be an overwhelming compliance and regulatory burden. The Enzyme cloud-hosted QMS application greatly reduces the work needed to accomplish the same deliverables. Per its namesake, Enzyme acts as a catalyst, or force-multiplier, to help get products to market faster.

Our Mission

Enzyme’s mission is to help life science companies commercialize faster without compromising patient care. We foster a culture of quality through modern software tools and expert guidance.

Our goal is to reduce the time and cost life science companies spend during the product development life cycle. Through our product, education, and support, we help companies commercialize faster.

Enzyme At A Glance

What We Offer To Customers

eQMS Web Application

A SaaS application that encodes a depth of quality & regulatory business processes that is thoughtfully integrated & friendly to novices and pros alike.

Quality System Document Library

A Full QMS set of procedures compliant to regulations & standards to which medical device companies must comply.

Services

For strategic accounts, we offer Regulatory and/or Quality consulting services, or “RaaS” and “QaaS” respectively). Through the Quality services, we provide support to companies as they set up their QMS and train their users. We can also provide internal audit support to help ensure they are ready for FDA inspections and Notified Body (the FDA equivalents in the European Union) audits.

As part of our regulatory services, we can help companies prepare their pre-submissions and full submissions for the FDA or a Notified Body.

How We Operate

Enzyme is a Remote First organization. Processes and tooling are set up to ensure a high level of transparency and accountability across the organization, regardless of whether an employee is on-site or remote.

Employees local to the SF Bay Area have the option to work from HQ. However, employees can work remotely from home, a coffee shop, or wherever they are most efficient, provided their work is getting done.

For the 100% remote team members, they can work from anywhere during business hours as long as they are available online for calls.

Performance Mangement (aka Objectives & Keys Results, OKRs)

Individual Performance Review

As per best practices and quality system procedures Enzyme continuously assesses competence. This is a suggested agenda for routine 1-on-1 meetings:

This will be summarized in an annual review.

Our Office

Focused Work and Asynchronous Communication

Our employees work varied hours from many global locations. This creates several asynchronous workflows that we strive to use to our advantage and allows great autonomy for individual contributors. Team and all-hands meetings are generally clustered during centralized ‘core hours’ so all who are needed can attend as per their normal work schedules.

We believe HIGHLY in the lesson of this cartoon by @detly

It’s far better for everyone’s concentration and sanity if we collaborate as though most things will get an answer eventually, but not necessarily right this second. The preferred first choice of action should be to post a message, a to-do, or a document about what we need explained or need to know. Then others can respond when they’re available.

There are exceptions. Extended, synchronous collaborations sometimes are needed. We use Slack, Zoom, and in-person collaboration when appropriate.

Teams that collaborate heavily should plan for more overlap. Async should bias for deep (aka Deep Work) concentration time, thereby improving productivity.

Enzyme IRL (In Real Life)

Once in the summer and once in winter we all gather to build relationships and share key updates.

This is an important complement to our remote-first, distributed structure.

Tools we Use

To successfully build our product, there are several tools we use on a daily basis.

Everyone

Product Development

Customer Operations & Marketing

Compensation & Benefits

Enzyme provides

Perks

Standard Holidays

On-call Period