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

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

Miejsce pracy: Łódź

Technologies we use

Expected

• Microsoft Office

About the project

In the R&D Samplers Hardware Team, we are supporting product life cycle projects related to the Samplers product design from the perspective of quality and delivery. Our goal is to maintain current products on the market and support future strategic initiatives. This includes but is not limited to working with CAPAs, complaints, quality issues, external suppliers and services, including plastic molding, manufacturing support, capacity and yield improvement, obsolescence, compliance with standards & regulations, market access, and cost improvement projects. We are a team of experienced engineers working on a wide variety of tasks within the strictly regulated medical field. Our tasks often require a holistic approach and cross-functional alignment. We very much value being open-minded and ready for exploring new areas.

Your responsibilities

• Maintaining product documentation
• Running individual tasks from Samplers' daily management board from start to finish
• Running projects as a lead person and executing on tasks being part of bigger projects within Samplers
• Initiating and coordinating engineering changes (ECR/ECO)
• Designing and documenting a feasibility study testing
• Conducting cross-functional discussions and alignments
• Documenting your work in the form of impact assessments, technical rationales

Our 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

What we offer

• Great Place to Work since 2015 - it’s thanks to feedback from our workers that we get this special title and constantly implement new ideas
• Employment stability - revenue of PLN 2.1BN, no debts, since 2006 on the market
• We share the profit with Workers - over PLN 76M has already been allocated for this aim since 2022
• Attractive benefits package - private healthcare, benefits cafeteria platform, car discounts and more
• Comfortable workplace – class A offices or remote work
• Dozens of fascinating projects for prestigious brands from all over the world – you can change them thanks to Job Changer application
• PLN 1 000 000 per year for your ideas - with this amount, we support the passions and voluntary actions of our workers
• Investment in your growth – meetups, webinars, training platform and technology blog – you choose
• Fantastic atmosphere created by all Sii Power People

Recruitment stages

• Send your CV
• Talk to us about your expectations
• Learn more about our projects and choose the best
• Start your adventure with Sii!

Sii Sp. z o.o.

Sii is the leading technology consulting, digital transformation, engineering, and business services vendor in Poland. We already employ more than 7 300 professionals and implement projects in a variety of industries for clients from many countries around the world. The Great Place to Work title, won 10 times in a row, proves that at Sii, we create a friendly work environment.

Sii ensures that all employment-related decisions are made solely on the basis of qualifications and competencies. We are committed to equal treatment of all individuals, regardless of any protected characteristics, and promoting a diverse and inclusive work environment.