R&D Sustaining Engineer (m/f/d)

Olympus Corporation; Berlin; Hybrid; EUR 70.000 - 100.000; Vollzeit

Benefits dieser Stelle

30 days annual leave

Up to 60% remote work + flexible hours

Holiday and Christmas bonuses

Corporate discounts for employees

Company pension and capital-forming

Company restaurant with subsidized,健康食

Employee Assistance Program

Deutschlandticket subsidy, parking, 2–

Zusammenfassung

Olympus Corporation in Berlin seeks an experienced Electrical Engineer to drive the electrical design of medical devices and manage lifecycle changes. You will collaborate with cross-functional teams to ensure regulatory compliance and manufacturability across in-house and external suppliers.

Ideal candidates have 4+ years in the field, strong measurement and PCB skills, and a proactive, team-oriented mindset in a multinational environment.

Qualifikationen

• Bachelor’s or Master’s degree in Electrical engineering or equivalent professional education.
• 4+ years of professional experience.
• Experience with analogue and digital measurement technology (oscilloscope, analysers).
• Knowledge of circuit diagrams and circuit board design.
• Desirable: process-oriented development of medical products.
• Independent and goal-oriented work style and ability to work in a team.
• Experience with standardization and certification of medical devices (IEC 60601-1, EMC, ISO, EN).
• Experience with Design Control (21 CFR 820), ISO13485, ISO14791, MDR and related regulations.
• Good or better written and spoken English.
• Strong collaboration skills and ability to work in a multicultural environment.

Aufgaben

• Provide support to products post launch and coordinate design/manufacturing changes as part of lifecycle management.
• Focus on electrical design of the system and components across subsystems.
• Maintain current knowledge of new product development and manufacturing technologies for medical device design.
• Evaluate feasibility, reliability and risk of concepts through testing and analysis to ensure performance, manufacturability, safety and cost meet requirements.
• Generate, modify and review design history file documentation in compliance with QSR, GMP, ISO and internal standards.
• Advance vendor activities in alignment with global sourcing for components and assemblies for prototyping or production.

Kenntnisse

Independent

Teamwork

English skills

Pioneering spirit

Collaboration

Multicultural environment

Analogue/digital measurement

Measurement tech

Ausbildung

Bachelor’s or Master’s degree in Electrical engineering

Tools

Oscilloscope

Analysers

Circuit diagrams

PCB design

Jobbeschreibung

Your Responsibilities

- Provide support to products post launch, coordinating design and manufacturing changes and improvements to meet defined specifications (esp. device and manufacturing requirements) as part of life cycle management (changes, QIS, CAPA etc.) in cooperation with other specialist departments, taking into account medical application requirements and economic requirements. This applies to both in‑house and purchased products and assemblies.

• The particular focus is on the electrical design of the system and its components, taking into account the various subsystems.
• Maintain a strong and current understanding of relevant new product development and manufacturing technologies and their application to medical device design to meet or exceed customer, company and project needs
• Evaluation and documentation of the feasibility, reliability and risk of concepts and / or prototypes through engineering testing and analysis in order to demonstrate that the product performance, manufacturability, safety and cost are consistent with the customer, regulatory and production requirements
• Generate, modify and review design history file documentation in compliance with relevant regulatory requirements e.g. Quality System Regulations (QSR), Good Manufacturing Practice (GMP), International Standards Organisation (ISO) and in accordance with company development standards (e.g. PDD, TDP) throughout the product life cycle to ensure the design is fully documented
• Progress vendor activities in agreement with global sourcing relative to communication of specifications, development schedules and tracking in order to obtain components, supplies or equipment to support prototype or product procurement and assembly
• Deliver manufacturable designs acceptable to operations by applying design for manufacture principles, implement and communicate feedback from manufacturing engineers, external suppliers and other sources to the R&D engineer

Your qualification

- Bachelor’s or Master’s degree in Electrical engineering or equivalent professional education

• 4+ years of professional experience
• Confident handling of analogue and digital measurement technology (oscilloscope, analysers)
• Experience with the creation of circuit diagrams and circuit board design
• Knowledge of the process-orientated development of medical products is desirable
• Independent and goal-orientated way of working as well as the ability to work in a team and a pioneering spirit
• Experience in the area of standardization and certification of medical devices (IEC 60601-1, EMC, ISO, EN).
• Experience in sustaining regulated devices under Design Control (21 CFR 820), ISO13485, ISO14791, MDR and knowledge of applicable regulations
• Good or better written and spoken English skills
• Strong collaboration skills with internal and external partners
• Ability to work effectively in a multicultural environment

Your benefits

- 30 days of annual leave

• Up to 60% mobile work possible + flexible work time model with overtime compensation
• Holiday and Christmas bonuses
• Corporate benefits discounts for employees
• Comprehensive company pension scheme and capital‑forming benefits
• Company restaurant with healthy food (subsidized)
• Employee Assistance Program of FamPLUS to support your health, mental and emotional well‑being
• Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
• Various subsidized company sports groups

About Olympus

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best‑in‑class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

For more information, visit

and follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA

Further information:

We value the diversity of individuals, perspectives, and lifestyles, and prioritize inclusion and mutual respect. We are committed to fostering a non‑discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.