Novanta

Solving complex challenges, delivering innovations that matter

Novanta is a leading global supplier of core technology solutions that give medical and advanced industrial original equipment manufacturers a competitive advantage. We combine deep proprietary technology expertise and competencies in precision medicine and manufacturing, medical solutions, and robotics and automation with a proven ability to solve complex technical challenges. This enables Novanta to engineer core components and sub-systems that deliver extreme precision and performance, tailored to our customers’ demanding applications. The driving force behind our growth is the team of innovative professionals who share a commitment to innovation and customer success.

Career opportunities
These are just examples of the types of job opportunities the company offers. A complete overview of job opportunities can be found in the respective career portal

Our Culture

The Novanta Way is how we build a high-performing culture, which enables us to achieve our growth goals. It starts with cohesive teams that are engaged and aligned around our vision and strategy, and who live our values and drive performance through the Novanta Growth System, which is the common way we operate.

The Novanta Growth System (NGS) is a set of tools and processes for deploying our strategy into developing innovative products and building commercial and operations excellence. We developed NGS in 2019, and in 2020 deployed mandatory NGS training programs for employees throughout the company. Companywide councils in specialized areas, such as operations, R&D, supply chain and sales & marketing, work together to further develop process excellence.

Design Assurance Engineer

This position is part of Novanta’s World of Medicine (WOM) business unit in Berlin. Specialized in the field of Minimally Invasive Medicine, WOM develops devices and accessories so that doctors can operate with small cuts. We produce Cameras, Insufflators, Medical Pumps, and tubing that makes diagnosis and treatment easier for everyone. Our insufflators and pump systems dilate cavities in the body and turn previously complicated surgeries into minor procedures. Together with customers, doctors, and technical experts, our teams continuously search for new ways to innovate.

Job Summary

  • Creation of a higher-level quality plan (VnV plan).
  • Creation and review of design verification and validation test specification for medical devices (devices and consumables)
  • Review of design control documents according to GLP, GDP, CFR820

Primary Responsibilities

Complex tasks within the framework of guidelines and specifications.

  • Within the framework of design guidance:
  • Creation of a superior quality plan (VnV plan)
  • Creation and review of design verification and
  • validation test specification for medical devices (equipment and consumables)
  • Review of design control documents according to GLP, GDP, CFR820
  • As part of the risk management process:
  • Part of the risk management team according to ISO 14971
  • Review of the systematics and completeness of the risk analysis
  • Evaluation of risk-reducing measures with regard to impact on severity of damage and probability of occurrence
  • Examination of the evidence for implementation and effectiveness of the measures
  • In cooperation with Industrial
  • Engineering/Quality Assurance-Production:
  • Involvement in the preparation of test specifications and test requirements for the series testing of medical devices
  • Other tasks:
  • Member of the product and design FMEA team
  • Failure analysis for field returns and during development
  • Methodical support and execution of NC/CAPA according to ISO 13485
  • Administration, adjustment or
  • maintenance of calibration of measuring equipment

Required Experience, Education, Skills and Competencies

  • Completed technical and/or physical studies
  • at least 3 years of professional experience
  • Experience with the topic of product quality in a highly regulated industry (medical device, automotive, aviation)
  • Theory and application of quality methods and techniques required:
  • Statistical methods and quality assurance
  • system testing
  • Hardware and software testing
  • reliability testing
  • English language skills (GER-B2)* required
  • Quality-conscious, trustworthy and reliable
  • Team player
  • Good communication skills
  • Structured and systematic way of working

Travel Requirements       

  • Willingness to travel to all locations and business contacts (<10%)

Lead Systems Engineer for Disposables

In our role as Lead Systems Engineer (f/m/d) for Disposables, you will act as a Medical tub set specialist (f/m/d) within our engineering team that focuses on the platform/ basis of our medical device development.

In your role as Disposables Specialist (f/m/d), you will lead and drive activities and processes concerning the introduction of new tube sets and disposables and the standardization processes.

One focus area of this role is the analysis of new requirements from the product teams regarding their impact on the Tub set platform architecture and materials used.

You will ensure that all projects related to disposables / tube sets will be conducted in a congruent and consistent manner, acting as a coordinator for these projects.

The work span areas from the writing, definition and improvements of the requirements for the tube sets´ sterilization processes, the topic of packaging and the control of material substances which are highly sensitive to handle.

The biocompatibility of our products will be a very important topic, being monitored by the Lead Engineer (f/m/d) for Disposables.

Our Specialist for disposable tub sets (f/m/d) will coordinate platform changes with the related product teams and engineering teams and as well as identifying relevant technical innovations and handling the integration of these innovations into the Tub set and medical device platform.

As our lead engineer (m/f/d) disposables for medical devices you will work cross-functional, participating in the development of business processes related to the developments within the WOM-Platform team.

Furthermore, you will train your colleagues on relevant work instructions regarding sterilization, and other specific topics.

Professional Profile Requirements to be successful in this role:

  • Several years of experience (5 - 8 years) in product development of sterile disposable products for medical devices.
  • Expert in product and process development for sterile products.
  • Highly skilled in requirements management, specifically validation and verification.
  • Ability to work independently and demonstrate interdisciplinary problem-solving skills.
  • Very good experience in handling of complex tasks, including analysis, problem-solving, for instance, root-cause analysis and CAPA processes.
  • -Ing./ Master degree in Chemical Science, Medical Technology, Materials Engineering, Natural Sciences, or related.
  • Expert knowledge of ISO13485 and sterilization aspects
  • Fluent conversational and written German language skills (C2) and proficient English communication skills.
  • Availability to work onsite in Berlin (Hybrid possible).

Personal Profile Requirements we are looking for

  • Quality-conscious and reliable.
  • Structured and systematic approach to work.
  • High level of abstract thinking.
  • Ability to prepare complex topics for decision-making processes.
  • Strong communication skills, intercultural and interdisciplinary

System Engineer Medical Technology

WOM, a Novanta Company is a pioneer and a worldwide leading manufacturer in medical technology. We are looking for reinforcement for our development team Insufflators in Berlin. If you like to work independently, break new ground in minimally invasive medicine with us and want to develop consistently, we should get to know each other better.

What we offer you

  •     Versatile tasks in an exciting working environment
  •     International teamwork
  •     Appreciation and respect
  •     Systematic further training
  •     Room for innovation
  •     Career prospects in an expanding company

Education

Dipl.-Ing./Master Electrical Engineering/ Medical Technology/ Mechanical Engineering or Materials Engineering/ Biology or equivalentTechnical requirements

  • Good to very good knowledge in system development of medical devices and/or software design
  • Implementation of the IEC 60601-1 family of standards for the electrical safety of medical devices
  • sound experience with the risk management process according to ISO 14971
  • good knowledge of written and spoken German and English (min. GER-B2)*

Personal profile

  • Quality-conscious, trustworthy and reliable
  • Willingness to travel to all locations and business contacts
  • Communicative skills
  • Structured and systematic way of working

Responsibilities

  • Responsibility for the technical realisation of new product developments - pumps and insufflators as well as their accessories (hose sets)
  • Technical contact person for customers, suppliers and internal departments
  • Analysis of external/internal customer requirements
  • GAP analysis for WOM Platform
  • Creation of the device or hose concept in cooperation with the platform department
  • Creation of system specifications (e.g. insulation concept with component selection) as part of the requirements specification phase
  • Definition of the features to be developed
  • Technical control of the technical project parts and content-related support of the associated work packages (target definition, DoD) together with the project manager and the R&D team
  • Responsible for product-specific risk management
  • Technical management of the device or hose set constructions (Alpha, Beta)
  • Responsible for the product-specific verification plans and their successful implementation
  • Creation and maintenance of technical documentation
  • Transfer of the developed products into production
  • Responsibility for the technical release of the products by the customer

Director PMO

This position is part of Novanta’s Minimally Invasive Surgery (MIS) business unit group and located in Berlin. Novanta offers highly reliable, precise and safe solutions that enhance system performance and improve patient outcomes. Insufflators, pumps and disposable tube sets, along with medical visualization and operating room integration technologies are the preferred solution for minimally invasive surgery applications.

Job Summary: Senior Director PMO

  • Establish a PMO that drives project management as a core discipline. Develop, maintain, and continuously improve project management processes, tools & templates (Scope management, Schedule management, Project Baselining, Project Change management, Risk management, Status reporting). Ensure that new standards are being adopted, incorporated in design processes, and reflected in products’ technical files.
  • Establish and maintain KPIs to provide maximum transparency of project status from a progress and quality perspective.
  • Provide Governance and Project Prioritization in close alignment with Head of NPI.

Primary Responsibilities

  • Establish a PMO that drives project management as a core discipline. Develop, maintain, and continuously improve project management processes, tools & templates (Scope management, Schedule management, Project Baselining, Project Change management, Risk management, Status reporting). Ensure that new standards are being adopted, incorporated in design processes, and reflected in products’ technical files.
  • Establish and maintain KPIs to provide maximum transparency of project status from a progress and quality perspective.
  • Provide Governance and Project Prioritization in close alignment with Head of NPI.
  • Manage and mentor project managers to ensure proper project planning and on-time, on-budget, on-quality project execution. Work with project teams on mitigations if any of the objectives are at risk.
  • Establish Project Status Reporting structure. Organize and lead report out at weekly senior management updates and phase gates. Ensure compliance with ISO 9001 and ISO 13485 standards.
  • Ensure a consistent and stringent execution of phase gate reviews.
  • Manage Technical Writing group, lead IP management, and manage Product Engineering, including MDR and VAVE.

Management tasks

  • Technical and disciplinary management of subordinate employees
  • Assignment, development and scheduling of employees according to requirements and skills
  • Conducting regular appraisal interviews and set personal objectives
  • Professional and personal development of employees
  • Hiring of new employees

General tasks

  • Implementation of the company and department strategy
  • Coordination with other departments on processes, interfaces and cross-sectional tasks
  • Participation in the annual budget and investment planning
  • Strict adherence to quality, work safety and environmental regulations and following instructions by quality/
  • environmental management as well as work safety management

Required Experience, Education, Skills and Competencies

  • Bachelor Degree in business or technical field, ideally Medical Device Technology or similar, MBA preferred
  • Project Management certification (PMI or similar).
  • Minimum of 10 years project management experience, including management of complex, large size technology projects. Experience preferably in medical device industry.
  • With 5+ years leadership experience, with established management and organizational style; including experience in managing through managers.
  • People manager - managing and developing team members into future leaders and top professionals.
  • Minimum of 3 years managing a PMO with multiple large and small sized projects.
  • Ability to establish and cultivate project management processes and tools in a regulated environment using agile methodologies.
  • Ability to establish and drive data driven project management culture.
  • Experience in multi-site, multi-project environment.
  • Track record of successful project execution and demonstrated experience in project management methodologies such as Agile and Waterfall.
  • Fluent in English and German language skills (GER-C1)*