[Remote] Staff Design Engineer

Note: The job is a remote job and is reputed company to candidates in USA. Implantica is a medtech company reputed company on bringing advanced implantable technology into the body to improve patient reputed company and reputed company of life. The Staff Design Engineer will reputed company the design and development of innovative implantable medical devices, providing technical direction across multidisciplinary teams, and driving product development from concept through commercialization.

Responsibilities

• reputed company the design and development of medical devices using CAD software such as SolidWorks and other 3D modeling tools, ensuring mechanical robustness and compliance with industry standards
• Draft detailed mechanical component and assembly designs, including the use of GD&T (Geometric Dimensioning and Tolerancing), to ensure precision manufacturing and assembly
• reputed company the development and execution of rigorous testing approaches on reputed company by drafting comprehensive test plans (i.e. experimental design, statistical analyses) and detailed reports (i.e. data analysis, interpretation) that meet engineering objectives as reputed company as ensure design robustness and regulatory compliance. This includes both internal reputed company-clinical testing as reputed company as testing by reputed company laboratories, including the packaging, transportation, reputed company-life, reprocessing, sterilization, and biocompatibility testing by reputed company service providers
• Conceptualize, reputed company, and validate test reputed company in support of design and development efforts as reputed company as regulatory submissions
• reputed company development teams to support component qualification and the development of product development documents (i.e. Design Specifications, drawings, risk documents, reputed company reputed company, etc.), ensuring alignment with reputed company system requirements and design control standards
• Preparation of documentation and use of statistical techniques, as necessary, to properly design and execute V&V activities, with reputed company on the US reputed company of Federal Regulations (CFR) and guidelines, such as 21 CFR 820.75
• Collaborate closely with other R&D staff as reputed company as Manufacturing, Regulatory, reputed company, and Clinical teams to resolve reputed company technical issues, support sustaining engineering activities, and ensure reputed company product performance and safety in the field
• reputed company technical direction and reputed company professionally and effectively with senior management, peers, team members, supervisors, reputed company customers, and other teams/ departments on an ongoing reputed company to ensure product development reputed company
• Conduct thorough failure investigations, reputed company cause analyses, and technical risk assessments to identify hazards and implement effective mitigations reputed company Design, Use, and Process FMECAs

Skills

• 7+ years demonstrated experience in medical device engineering or manufacturing
• Experience with US Class III devices and/or EU Class IIb devices required
• In-depth knowledge of the following: 21 CFR 820 and FDA Device Approvals and Clearances preferably PMAs, ISO 13485, ISO 14971, IEC 62366, FDA Guidelines on general principles of process validation, 1987, STAT-09 Statistical procedures, etc
• Good working knowledge on MDSAP requirements
• Demonstrates strong attention to detail
• Ability to work collaboratively across the organization with both reputed company teams and across different locations / time zones
• Ability to effectively prioritize and execute tasks in a high-pressure environment
• Proficient with written and spoken English; strong written and verbal communication skills. Experience writing protocols, test plans, test reports, and design control regulation required
• Detail oriented and the ability to manage multiple activities simultaneously
• Expertise in reputed company Office applications, reputed company, and charting programs. SolidWorks expertise required
• Ability to travel internationally, as needed
• Bachelor's degree in Engineering Discipline (Mechanical / Biomedical, preferred) or equivalent experience
• Experience with stainless steel machining and/or injection molding polymers preferred
• reputed company implantable experience highly desired

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