Systems Engineer (Oticon Medical)

Oticon Medical; København; Hybrid; DKK 650,000 - 900,000; Full time

Job summary

Oticon Medical BAHS seeks a Systems Engineer for our R&D team to verify products and drive design output using Systems Engineering methods. You will work across the development project, supporting verification activities and collaborating with engineering, QA and regulatory affairs.

You will contribute to verification strategy, analyze requirements, participate in design reviews, and ensure compliance with safety and regulatory standards while supporting a globally distributed team.

Qualifications

• Master's degree in engineering (electronics, software or related)
• Minimum 5 years of verification experience in medical devices or regulated industry
• Excellent communication and collaboration in cross-functional teams
• Proficiency in English; Danish/French/Swedish considered a plus

Responsibilities

• Provide input and execute the R&D verification strategy in development projects
• Assist in analysis of product requirements from a verification perspective
• Participate in design reviews as responsible for project verification
• Interface with departments to ensure compliance with safety and regulatory standards
• Ensure technical approaches meet quality and regulatory requirements

Skills

Verification

English proficiency

Team collaboration

Communication skills

System engineering mindset

Education

Master's degree in engineering (electronics or software)

Tools

Systems Engineering tools

Job description

Oticon Medical BAHS specializes in developing, producing, and distributing advanced bone-anchored hearing systems, including long-term implants, sound processors, software, and surgical tools. We are a global leader in hearing solutions, and we are currently looking for a Systems Engineer to our Research & Development Team. The team is spread across three sites, Copenhagen in Denmark, Gothenburg in Sweden and Nice in France. You will work at the Danish site, reporting to the Director of Systems Engineering. The main responsibility is to verify the products we are developing. You play both an execution role in the development project and an advisory role in the SE team, having a special focus on the verification and design output activities for our products and software solutions.

Main Working Relationships:

You will collaborate with various stakeholders in our product development (R&D, quality assurance & regulatory affairs, operations) and with external partners providing elements of our product platform (eg. chipsets and software). We foster a culture of mutual respect and support all teams, ensuring that everyone feels valued and empowered.

Your Main Tasks:

• Provide input and execute the R&D verification strategy in development projects
• Assist in the analysis of product requirements and specifications from a verification perspective
• Participate in product design reviews and team meetings as responsible for project verification
• Interface with all departments to provide guidance on the use of methodologies, tools, and compliance requirements with applicable safety and security standards for the product
• Ensure technical and methodological approach is accurate, adequate, and compliant with quality and regulatory requirements

Your Profile:

In general, we are looking for a new employee that will help us move forward with a higher level of understanding of the verification and design output using Systems Engineering methods and tools.

Critical expertise for the position:

• Master's degree in engineering in the field of electronics, software, or other relevant engineering disciplines
• Minimum of 5 years of verification experience in the medical device industry, or similar experience in another regulated industry with adequate systems engineering practices
• An inclusive and team-oriented mindset that thrives in a collaborative environment with focus on achieving results in a pragmatic way
• Energetic, motivated, and proactive person, capable of working in a diverse team in a developing organization
• Strong interpersonal skills and a supportive attitude to help build a positive team dynamic
• Excellent communication and influence skills - written and verbal - suitable for a wide range of stakeholders both in projects and management
• Proficiency in English (reading, writing, speaking). Some proficiency in either Danish, French or Swedish will be considered an added benefit, bringing the teams closer together.

Desired Skills:

• Knowledge of standards applicable to verification of medical devices (eg. ISO 13485, ISO 14971, IEC 62366, IEC 60601 standards)
• Knowledge and experience in SW as a medical device, eg. CD/CI, distribution and cyber security aspects
• Knowledge of INCOSE ways of working, even better an ASEP/CSEP certification
• Knowledge of the field of hearing implants and/or hearing aids and/or "hearables"

Working Time and Duration:

• Flexible hours to support work-life balance
• Limited remote work (1 day a week) possible
• 37 hours per week

Why Oticon Medical?

Collaboration is our greatest strength, as we believe the best results come from a team-driven approach. We foster a culture of trust, openness, respect, and kindness. We also offer flexible working conditions and prioritize work-life balance. By joining our growing global company, you will directly contribute to enhancing the lives of individuals worldwide.