Bio Medical Device AS (BMD) is a Norwegian company, founded in 2018, with the objective to develop and commercialize a new revolutionary medical device technology intended for treating patients with urinary stress incontinence. BMD is set up as a company to develop Incontinence Valve System (IVS) into a global commercial medical device, serving multiple incontinence related indications. Our lead investors are Codee Holding and Planet 9 Venture, with founders and employees as key owners. BMD´s vision is to restore urine control for the millions of men and women suffering from incontinence. Our user-friendly solutions will allow patients to enjoy their lives without urine leakage. Our mission is to develop a revolutionary medical device to improve the health and quality of life of people suffering from urinary incontinence. BMD is a company thriving on shared values, with patients at the center of all we do. Working together, these values allow us to develop products and services that genuinely will make a difference to people’s lives around the world. For more information, please visit www.bmdevice.com
Are you passionate about medical device technology?
Do you want to succeed in an exciting start-up company?
Do you want to contribute to the transformation of healthcare?
To achieve our vision and to take the next step in our journey to develop
our unique device we are recruiting a:
Chief Technology Officer (CTO)
The objective of the CTO will be to oversee all R&D efforts including new product development and design changes at BMD and contribute with technical know-how during development, design transfer, manufacturing, quality control, and supply chain/logistic services. You will furthermore proactively suggest product innovations and improvements as per company needs and strategies. A future opportunity as CEO for the company could be possible, for the right candidate.
- Lead the BMD R&D team including consultants.
- Define the R&D organizational structure and drive recruitment of new R&D and Manufacturing staff.
- Design control including design verification and validation activities, and the related internal procedures, such as risk management.
- Partner with cross functional teams in clinical/regulatory/marketing to develop overall R&D strategy and plans including key deliverables, corporate goals & objectives, timelines, budget projections, and key decision points.
- Accountable for development and maintenance of the Technical Documentation/Design History File (DHF), the Device Master record (DMR) and the Design History Record (DHR).
- Select, establish, approve and follow-up on CRO`s, CMO`s and consultants as appropriate.
- Establishment and revisions of Supplier Agreements.
- Design Transfer to and between manufacturing sites.
- Responsible that development and manufacturing are conducted in accordance with the BMD Quality Management System, product specifications and regulatory requirements.
- Responsible for preparation of regulatory documentation for use in applications for start of clinical studies and regulatory approvals/certifications (e.g. CE-mark, PMA, 510k), in collaboration with Regulatory affairs.
- MS or PhD in a relevant science / technical discipline (e.g., mechanical engineering, electrical engineering).
- 5+ years of experience in leading advanced medical device R&D efforts. Recent experience in a small/start-up company point-of-view is highly desirable.
- Proven track record in establishing and maintaining clinical and commercial manufacturing and supply chain of complex medical device systems through CMOs.
- Insight and experience in regulatory requirements and quality assurance including ISO 13485, and 21 CFR part 820.
Who are you?
As a person you are innovative, business oriented, interested in results and to solve problems proactively. You are structured and organized in your way of working and have a clear focus on initiatives and execution. You are a good team player and you value cooperation and always show responsibility for your own work and for contributing to a good collaboration with others. You can simultaneously handle many tasks and short deadlines and interact and communicate with several different stakeholders and functions. You have an entrepreneurial mindset with a high interest to work in a small and passionate team. You inspire others through your dedication and your passion, and you create a culture of ownership and commitment in your environment.
This recruitment is handled by H&P Search & Interim. Please contact us for more information. Alternatively, you can apply directly by uploading your resume and sending us an email.
We look forward to your application!
H&P Search & Interim
Torbjörn Ströberg, firstname.lastname@example.org, tel 0703-778 774
Karin Tomin, email@example.com, tel 0726-013 619
Johan Walde, firstname.lastname@example.org, tel 0761-870 612