Software Medical Device Quality Engineer
About the job
SCARLETRED - The worldwide leader in standardized skin imaging and AI powered objective skin analysis. Our mission is to design, develop and deliver certified Software as a Medical Device Products and cutting-edge AI-powered data analysis Services, that make it possible to standardize the process of skin imaging, objectify disease and treatment assessment, and to accelerate data collection and analysis in clinical trials and medical routine. We are growing and seeking new, experienced and hands-on team members who think outside of the box, deliver unique ideas and like to work in a fast-paced digital health and medical research environment. You are reliable, ambitious, your heart beats for clinical trials, digital health and artificial intelligence. You like to prove yourself and like to work in an international team and highly collaborative job environment.
We are looking for an experiences Software Device Quality Engineer who is who develops and has stewardship of the overall device and combination product quality strategy of the company. In this job you will support our mission in delivering the best possible product and service scope for our customers in biopharma, cosmetics and medical industry. You will interact with the software development team, PMs, C-level management and report directly to the CEO.
- Execute activities for the Device Quality function supporting software medical device and combination products for all phases of the product lifecycle including design, development, manufacture, distribution, and product support processes.
- Ensure all device and combination product quality and regulatory standards/requirements are met.
- Provide quality support for, but not limited to, internal/external inspections, product submissions/approvals, CAPA, complaint handling, and change control
- Represents DQ in support of Scarletred’s’s medical device and combination product development efforts (e.g., new software applications, changes to existing software applications, bug fixes, etc.) throughout clinical development, design transfer, and commercialisation.
- Accountable for DQ deliverables (e.g., risk management file documents, quality plan, trace matrix, software validation, etc.) in oversight of 62304 Class 1m, 2a and SaMD / decision support system
- Accountable for risk management deliverables (e.g. risk management plan, FMEA, hazard analysis, risk management report) and quality planning activities for assigned projects.
- Responsible to ensure that assigned medical device and combination product development projects are in compliance to IEC 62304, MDR, ISO 13485, ISO 14971, and other relevant global regulations and international standards.
- Provides DQ technical quality support for regulatory filings in EU, USA and Japan
- Provides DQ technical support including planning, execution, and reporting of design verification and validation activities for SaMD.
- Leads quality improvement initiatives and design improvements within lifecycle management of assigned medical devices or combination products.
- Responsible for quality assessment during supplier qualification for assigned development projects.
- Supports internal and external audits including readiness as an SME on product lifecycle documentation.
- Can effectively lead and execute commercial lifecycle management support activities including but not limited to change control, deviation investigation, CAPA, and complaint handling
- Bachelor’s or Master Degree in Engineering or equivalent technical discipline required, and at least 5 years of experience working with software medical devices in Quality Assurance and/or Quality Engineering roles;
- Extensive knowledge of international regulations for Device and Combination Products with full understanding of European, International, and US requirements for Design Control and Risk Management guidelines, Change Management, CAPA, with primary emphasis on ISO 13485, ISO 14971, MDR and IEC 62304.
- Experience with commercial development and regulatory filings
- Experience working with external manufacturing partners
- Advanced Degree and Experience working in Pharmaceutical/Biotech/Device industry, Software Application Medical Device Engineering background preferred, Quality IT; Auditor certification.
- Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team.
- Strong decision-making skills even in times of uncertainty. Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs.
- Ability to work productively on a cross-functional team model.
- Build strong working relationships with Device Quality partners and other business process owners
- Accountable for analyzing product information, driving improvements in process as a result of product knowledge.
- Full time employment at our headquarter in Vienna
- Motivated and agile team with a common vision and a flat hierarchy
- A lot of room for professional development and individual mentorship
- Working in a growing company with leading international medical partners and customers in biopharma and cosmetics industry
- The gross annual payment for this job vacancy is minimum EUR 50.000 on a full-time basis.
- Overpayment is possible depending on education and working experience (Junior / Senior).
Please submit your application in English or German
SCARLETRED is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, sex (including pregnancy), gender, national origin, citizenship, ancestry, age, physical or mental disability, military status, status as a veteran or disabled veteran, sexual orientation, gender identity or expression, marital or family status, genetic information, medical condition, or any other basis protected by applicable federal, state, or local law, ordinance, or regulation.