DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.

Responsibilities:

Overall:

• Lead engineering team in support of product development and ensure all work is performed per internal, ISO and regulatory standards.
• Ensure execution of detailed engineering analyses & documentation to support design development and support process transfer
• Apply Project Management tools to track, trend, communicate and drive projects to meet deliverables.
• Compiles high level timeline and resource needs. Creates, tracks, and meets project schedules, plans, and budgets.
• Directs and implements a comprehensive product development strategy.
• Coordinates all aspects of product development activities of R&D/Product Development, including integration of RA, QA, Operations, and Clinical.
• Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed.
• Assesses priorities and makes assignments to direct reports to ensure project and company priorities are met.
• Performs supervisory responsibilities for direct reports, including but not limited to, performance reviews, recommending salaries and promotions, training, interviewing, and hiring decisions and disciplinary actions.
• Identifies development needs and potentials of employees and provides or recommends project assignments and training to increase expertise to meet current or future needs
• Provides technical support and feedback for direct reports.
• Actively participates in training and providing input to training of employees on department procedures and policies
• Coordinates with team members, internal and external suppliers and outside professionals to ensure project output meet users’ needs as well as applicable regulatory requirements.
• Provides input, feedback, and maintenance for department and/or company procedures and policies.
• Oversee design transfer from R&D to Manufacturing.
• Produce and manage plans, reports, specifications, SOPs, forms, and other documentation to support Manufacturing and/or Manufacturing Development activities. Generates, reviews, and approves documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.
• Ensures processes, documents, materials, and equipment are compliant with applicable regulatory requirements including ISO13485, ISO 14971 and cGMP.
• Work closely with QA to maintain compliance
• Participates in investigations related to Nonconformance and/or Corrective and Preventive Actions related to manufacturing
• Support Regulatory Submissions.
• Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective products to patients.

Qualifications:

Education & Experience:

• Engineering degree desired or equivalent experience in related job field
• 8+ years related experience in Design/R&D or manufacturing environment and 2+ years of managerial level experience
• At least 5 years of relevant experience working under FDA QSR/ISO 13485 and GMP regulations. Experience working in a Medical Device or regulated industry preferred.
• Experience with risk assessment ISO 14971.
• Familiarity with auditing practices.
• Proven track record in technology development and/or early-stage R&D; capable of articulating a strategy for progressing towards a loosely defined research goal.
• Experience with IQ/OQ/PQ

Skills & Abilities:

• Strong data analysis and troubleshooting skills.
• Continual improvement process experience
• Strong organizational and communication skills, including technical writing
• Expert level knowledge with new product development process and demonstrated experience leading products from concept to commercialization.
• Strong working knowledge of Medical Device Design Control regulations/requirements
• Ability to work well with people at all levels.