Design Quality Engineer

Elvie | Bristol, United Kingdom
Flexible hours
Various work from home options
Dog friendly
Employment type
Full time

Elvie are looking for a Design Quality Engineer to join their team.

Life at Elvie - Meaningful work. Exceptional people

At Elvie, we don’t believe women's bodies are the problem. Instead, we believe the problem is that the needs of women’s bodies – and therefore, lives – have been ignored, misunderstood, and underestimated.

Founded by Tania Bolder in 2013, Elvie has been improving women's lives through better – and smarter – technology ever since. We develop innovations that meet the unique needs and complexities of the female body so that women can take charge of their health across every life stage.

Our first product, Elvie Trainer, is a multi-award-winning device bringing hospital-grade pelvic floor care to the hands of women everywhere— it was even a gift in the Oscar Nominee Goody Bags! And now, we're proud to say that we're part of the NHS Supply Chain in the UK.

Our second innovation was Elvie Pump. Launched in 2019, it's the world's first silent, wearable breast pump, enabling women to pump wherever they please— even the catwalk at London Fashion Week. It’s since won numerous awards, including the Times 100 Best Inventions of 2019 and ‘Wearable Design of the Year’ at the Dezeen Awards. The initial success of our wellness tools gave us the means to expand our breastfeeding range to include Elvie Curve and Elvie Catch, both designed to give mothers total comfort and confidence.

As a business, Elvie has received more than 30 awards (including the prestigious Red Dot Design award). We’re ranked as one of the 15 startups ‘To Watch’ by The Sunday Times and Business Insider and ranked as the 13th fastest growing business in the UK by Syndicate Room. Our founder and CEO, Tania Boler, is regularly profiled in top-tier media titles, and, in 2021, Tania was named GLAMOUR’s Women of the Year: Technology Gamechanger.

In July 2021, Elvie announced an $80 million Series C funding, the number one position and biggest raise in an initial fundraising round in the femtech category.

What does it mean to work at Elvie?

You will be surrounded by people who want to improve everything and everyone around them. People who are passionate about our mission. People who are driven to solve tough problems and constantly consider the best ways to improve the health and wellbeing of women.

We're deeply proud of our values, which are intrinsic to the way we behave every day. We take them seriously because we want our culture to thrive:

  • We make an impact - we are mission driven and not afraid to break boundaries. We relentlessly focus on going the extra mile to solve problems
  • We are fearless innovators - we are passionate, curious and data-driven. We continuously embrace change and innovation
  • We are in it together - we fail and learn fast, always as one team, and have fun along the way. We stay authentic and embrace our differences

About the role

Elvie has a need for a detail-oriented, passionate and dynamic individual with a desire to be an integral part of our growing Quality team. You respect rules and regulations but are not afraid to do things differently and challenge ‘business as usual’. You are able to understand the needs and challenges of the cross-functional teams that successfully support and drive products to market; from R&D and Product Development, through Operations, Manufacturing, Sales and Marketing. You are organised and logical and can form a clear path through the noise when complex decisions need to be made. You can develop plans of action and communicate them with confidence to 3rd party suppliers and the different functions within the business.

You will have experience working within the Medical Device industry, in a Quality and Regulatory focused role. You are excited by the prospect of defining the gold standard for quality, design documentation and document control in a rapidly growing business.

What you’ll be doing

New Product Development

  • Partner with R&D and supporting functions to deliver new products to market in compliance with required quality requirements and processes.
  • Guide the new products and improvement project teams through consistent, compliant and lean delivery according to Design Control and Risk Management processes.
  • Support the development of plans, test methods, reports and other quality documentation required for the Design History Files.
  • Maintain complete and compliant Design History Files in the eQMS.

Product and Process Continuous Improvement

  • Support the continual improvement of Quality System processes and tools that support the product lifecycle.
  • Work closely with our Customer Care to recover and correctly interpret insights from the field.
  • Help define proposed improvements with our Engineering team and implement proposed improvements with our Manufacturing teams through consistent and robust ECO’s.
  • Help drive improvements and to create a proactive and functional eQMS with a value-added approach to Quality Management Systems.

Regulatory and Compliance

  • Support the development of regulatory submissions for new products and country expansions, including 510(k) and product Technical Files.
  • Support CAPA, SCAR and NCR investigation and administration.
  • Support the maintenance of calibration activities and records.
  • Carry out internal audits when required.

Requirements

  • A degree in a relevant engineering, design or science discipline (or equivalent qualification).
  • Appreciation for all stakeholders involved in new product development.
  • Experience in consumer and medical device product design and development.
  • Developing Quality Management Systems and the ability to interpret regulations.
  • Experience ensuring a high level of compliance with MDD 93/42/EEC Medical Devices Directive, MDR, ISO 13485, 21 CFR 820, and cGMP
  • Experience in CAPA investigation and root cause analysis.
  • Experience in Risk Management tools and techniques (ISO14971)
  • Experience in the use of electronic Quality Management Systems and electronic Document Control.
  • Experience in IEC60601-1 and IEC 60601-1-2 would be an advantage.
  • Experience in auditing to ISO 9001 or ISO 13485 would be an advantage.
  • Able to review and understand hardware, firmware and software requirements and specifications.
  • Must be familiar with commonly used productivity & statistical software such as Microsoft Office and Google suite.

Benefits

Elvie is at the crest of a wave! Founded by women's health expert Tania Boler and tech entrepreneur Alex Asseily, Elvie is a collection of bright and motivated team members working across the business to shape the emerging femtech industry.

We are passionate about creating disruptive products that address the challenges that matter most to women and dismantling the taboos around women’s bodies. Here, you can be part of a business and brand that has a positive and meaningful impact on the world, while learning a great deal and having fun.

What are some of the perks of working at Elvie?

We are looking after you. As well as the chance to develop products with real work impact and working with dedicated and passionate colleagues, our benefits have flexibility and wellbeing in mind with

  • Flexible work environment built on trust and autonomy
  • Employee / friends & family discounts on Elvie products
  • Annual personal development allowance & unlimited access to our learning & development platform
  • A tax-efficient group pension scheme with SmartPension
  • A tax-efficient charity donation scheme
  • Life Insurance with Yulife
  • Medical, Dental & Optical cash-plan
  • Employee Assistance Program for you and your family
  • Generous employee referral program
  • Cycle Scheme & Tech Scheme
  • YuLife Well-being app & access to SmartHealth app with unlimited GP appointments for you and your family, plus various well-being initiatives throughout the year

At Elvie, we believe in having diverse teams in which everyone can be their authentic self is key to our success. We encourage people from underrepresented backgrounds to apply and we don't discriminate based on race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, marital status, disability or age. We are a family-friendly employer with a culture based on trust, autonomy and flexibility, and are working on making our offices wheelchair friendly and breastfeeding friendly. We do our best to accommodate part-time requests and flexible requests as much as possible. We are also a member of UK Tech Talent Charter and proudly working in partnership with myGwork and Women's tech hub.

Elvie
Femtech
Scale-up
Tech for good
View company profile
Flexible hours
Various work from home options
Dog friendly