Project Manager, R&D, Surgical Tables

Today's Stille is the result of nearly 180 years of innovation in the service of healthcare, ever since Albert Stille founded the company in 1841. Since the start, we have manufactured and marketed premium quality surgical instruments that facilitate the work of doctors and surgeons and made new surgeries possible. Stille's vision is that with our products we will create the conditions for surgical perfection "Surgical perfection. For life".
If you are a Project Manager and are attracted by being part of a company within medtech that places great focus on competence, product quality and close and personal customer relationships then you can be the right person for this position!
The team spirit, quality focus and pride in our craftsmanship are strong at Stille and you will be surrounded by colleagues who are considered some of the best in the industry.

Why do you want to work at Stille?
We offer an exciting, independent, and challenging job, a service with freedom under responsibility, with great opportunities in a future industry and a company in strong development. We will give you responsibility and have full confidence that you as an expert in the field have the best solutions. Not only do we have a strong belief that technology makes the world better, but we also believe in people and are convinced that your development is our development. We know that our shared competence becomes stronger when we help each other and care.


About the job
In this role, you will work in a R&D team designing operating tables and peripheral equipment to our worldwide customers. Some of your main tasks and responsibilities will be:
Holistic management of projects to develop medical products delivering new innovative clinical solutions - from the initial concept start until delivery and introduction in the market.
Responsibility for project objectives and scope, requirements, and balancing of goals, schedule (timeline), quality, and budget.
Tracking and reporting of deliverables and progress.
Facilitate project team meetings with agendas, minutes, and actions.
Create the project documentation with respect to Design and Development Process.
Ensure compliance with quality standards and regulatory requirements (FDA, CE Marking, ISO 13485).
Ensure deliverables are met and in accordance with Quality Management System and Business policies.
Management of communication, reporting, and escalation to program management.
Responsible for Technical Documentation and Design History File of the products.
Responsible for design verification and validation protocols and reports, design inputs and outputs, specifications, risk documents, and regulatory submissions.
Responsible for project risk mitigations and deviation handling.
Communication and intradepartmental activities with QA & RA and production.


Who are you?
Personal suitability is of great importance, and we believe that you have a strong commitment, a good ability to cooperate, but that you are still confident in working independently. You understand the importance of achieving results, meeting deadline, and ensuring high quality in your work. You have a desire to learn new things and enjoy creating results and achieving goals both individually and together with the rest of the team.
In the team, we are helpful and supportive, and we hope you are the same. We believe that people around you would describe you as communicative, result driven, and structured.
You are a trained project manager having at least three to five years track record in project management. Preferably you also have experience from Medical Devices and knowledge of MDD, MDR, FDA regulations and harmonized standards.
You genuinely like technology but also people. You thrive in social contexts, are safe and calm and handle both projects and individuals. You are enthusiastic, committed but also educational and listening.
You are a social person and through your skills and professional approach, you find it easy to build long-term relationships and create trust and confidence both internally and externally. At the same time, you are effective, results-focused and solution-oriented, without risking quality and safety.
Of course, you handle MS Office without problems and since we are an international company you speak and write unhindered in English and preferably also Swedish.

Qualifications
B. Sc or Master’s degree in Engineering (Mechanical, Electrical, Mechatronics, Bio-Medical, Embedded System, Automation, Robotics) or equivalent.
5+ years of Project Management experience in product development (R&D or NPD) or equivalent.
Proven track record in Project Management within regulated environments, preferably medical devices.
Relevant related technical experience or background in the regulated medical devices industry (e.g., ISO 13485; CFR21 part 11, IEC62304, others).
PMP certificate (or equivalent) will be a strong asset.


Other
Stille headquarter, production and R&D is located in Torshälla (Eskilstuna).
Application
Please submit your application (CV and cover letter) via our website https://www.stille.se/about-us/working-at-stille/project-manager-rd-surgical-tables/
We work with ongoing selection and interviews, which means that the position may be filled earlier than the last application date, so please send your application as soon as possible, at the latest January 29th 2023.