Control Design Engineer (Medical Device)

Fusion Life Sciences Technologies LLC; Warszawa; Híbrido; PLN 432 000 - 589 000; Tempo integral

Resumo da oferta

Fusion Life Sciences Technologies LLC is seeking a qualified engineer to harmonize design controls and risk management for a medical device integration. You will support cross-functional teams, author remediation protocols, and potentially lead feasibility workstreams in new product development and manufacturing transfers.

Responsibilities include planning, coordinating deliverables with partners, developing specifications, and obtaining cross-functional approvals for design control, risk

Qualificações

• Bachelor's Degree in Engineering and 3 years of relevant experience or equivalent.
• ABET-accredited school in Mechanical/ Biomedical/ Bioengineering/ Materials/ Chemical/ Polymer Engineering or related field strongly preferred.
• 3-5 years of full-time engineering experience in regulated medical device product development preferred.

Responsabilidades

• Harmonizes design controls and risk management procedures from a new acquisition with global processes.
• Supports integration activities by authoring remediation protocols and guiding integration strategy decisions.

Conhecimentos

Communication skills

Regulatory knowledge

Statistics in engineering

Formação académica

ABET-accredited engineering degree

Engineering degree in Mechanical/Biomedical/Materials fields

Descrição da oferta de emprego

Location: Warsaw, IN (3days office & 2 days Remote)

Expected Job Duties

• Harmonizes design controls and risk management procedures from a new acquisition with the global design controls and risk management processes.
• Supports integration activities by authoring remediation protocols and assisting the team reaching the correct decisions on integration strategy.
• May serve as technical lead or project manager for feasibility workstreams and small-scale, lower-complexity projects involving new product development, technology integration, design changes, or manufacturing/sourcing transfers under appropriate supervision.
• Creates and communicates project plans, timelines, budgets, resource needs, technical deliverables, decision criteria, risks, contingency plans, and status updates to stakeholders and leadership.
• Applies understanding of orthopedic infection prevention and treatment practices, clinical workflows, product intended use, and applicable regulations to support review of site documentation to identify any gaps or opportunities for improvement with guidance from technical and cross-functional leaders.
• Plans and coordinates deliverables with cross-functional teams and external partners.
• Develops product and process specifications, identifies critical-to-quality attributes, and supports quality control strategies based on intended use, design requirements, material and biological performance, infection-relevant performance attributes, and user risks.
• Authors, reviews, and obtains cross-functional approval of design control, risk management, regulatory, and evidence-supporting documentation, including materials for regulatory activities associated with the integration.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Up to 25% to the new site to collaborate between the teams.

Skills:

What Makes You Stand Out

• Demonstrated strong written and verbal communication skills, with the ability to communicate technical information to cross-functional and global audiences. Specifically, experience writing procedures, protocols, and technical rationales is preferred.
• Working knowledge and familiarity with the following Medical Device Standards / Regulations: 21 CFR Part 820 QSR (2024), ISO 13485, ISO 14971, MDD, MDR, IEC 62366-1, ISO/IEC 27001, BS EN 62304. Familiarity with drug-device combination products and software as a medical device is preferred.
• Demonstrated working knowledge of statistics applied to engineering studies, including sample size rationale, design of experiments, and hypothesis testing; Minitab experience desired.

Education:

Education Requirements

• Minimum Requirements: Bachelor's Degree in Engineering and 3 years of relevant experience or equivalent experience.
• Degree from an ABET-accredited school (or global equivalent) in Mechanical Engineering, Biomedical Engineering, Bioengineering, Materials Science or Materials Engineering, Chemical Engineering, Polymer Engineering, or a related engineering discipline highly preferred.
• 3-5 years of full-time engineering experience in regulated medical device product development highly preferred.
• Experience with orthopedic implants, medical software, biomaterials, antimicrobial technologies, wound management, coatings, or local drug delivery is strongly preferred.