Control Design Engineer – medical compliance (f/m/x)

On behalf of a global medical technology company, we are seeking an R&D Specialist to support lifecycle management and continuous improvement of hardware products used in a highly regulated healthcare environment.

In this role, you will contribute to product maintenance and development activities, including quality improvements, supplier collaboration, manufacturing support, compliance initiatives, obsolescence management and cost optimization projects. You will work closely with cross-functional teams to ensure product quality, reliability, and market availability.

We are looking for an experienced engineer who enjoys solving complex technical challenges, collaborating across disciplines, and exploring new areas within product development.

Your responsibilities

• Maintain and update technical product documentation throughout the product lifecycle

• Coordinate and execute engineering activities related to product maintenance and improvement

• Lead smaller projects and contribute to cross-functional development and lifecycle management initiatives

• Initiate, coordinate and implement engineering change activities

• Plan, execute and document feasibility studies and technical evaluations

• Collaborate with stakeholders across R&D, Quality, Regulatory, Operations and Supply Chain functions

• Prepare technical documentation, including impact assessments, risk evaluations and engineering justifications

• Support quality, compliance, supplier, manufacturing, and continuous improvement initiatives

Requirements

• Engineering background (M.Sc.) in Mechanics, Materials Science, Biochemistry, Biomedical engineering, or similar

• Minimum 5 years of experience in a similar position in medical / pharma industry

• Good understanding of Design Control principles

• Knowledge of medical standards and regulations and their applicability to different markets

• Experience in working with product-related documentation

• Expert skills in MS Office

• Basic knowledge in statistics

• Strong analytical skills (collaboration, creativity, critical thinking, data analysis, problem solving, research)

• Ability for business travelling mainly to the Stargard site (max 2-3 days/month)

• Fluent English in speaking & writing

• Fluent Polish required

• Residing in Poland required