Post Market Process Engineer - Health

Job Description

Summary

Posted: Oct 19, 2022 Weekly Hours: 40 Role Number: 200311100 Our ever-evolving suite of fitness and Health features in iPhone and Watch are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our business practices - strengthening our dedication to leave the world better than we found it. If you care deeply about impacting user health in meaningful ways, we'd love to talk with you. The Regulatory & Quality team is looking for a Post Market Process Engineer to support improvement of post market structure through implementing new processes and improving existing ones while leading sustaining efforts for health related projects. This position will be based in either Cupertino, CA or Austin, TX.

Key Qualifications

Key Qualifications

• Knowledge of FDA’s 21 CFR 820, 21 CFR 803, ISO 13485:2016, ISO 14971, MDD, EU MDR
• 3+ years of direct work experience in medical device quality functions, CAPA, complaint handling, or field action is preferred.
• Proven success on implementation of processes/procedures to improve efficiency and innovative thinking
• Experience developing and implementing processes for new product development activities
• Ability to succeed in an ambiguous and fast paced environment

Description

Description The Engineer is part of the larger post market surveillance (PMS) team supporting Apple’s medical products. This team is responsible for customer feedback and post market related activities. We are looking for someone who is flexible and can take initiative in leading efforts in post market process improvements and new process development. IN THIS KEY ROLE, YOU WILL: - implement innovative, scalable and efficient processes to further streamline processes - Further improve and maintains post market product surveillance established procedures and resources. - Work with various cross-functional teams in ensuring the PMS process remains compliant - Remains advised of new or revised PMS regulations/guidelines and assess process impact - Collaborate and work closely with post market manager to drive process improvements, meet changing regulation requirements that allows for scalability. - Lead post market activities for new product development and introduction. - Perform analysis of current post market processes; draw conclusions and make appropriate recommendations - Process customer feedback and related investigation and reportability assessment - Monitor and analyze complaint data to identify trends, issues or systemic discrepancies and initiate immediate remedial action, if appropriate. - participate in generating reports for complaint data, metrics and trends - Perform other quality system duties (e.g., CAPA, Internal Audits, etc.), as assigned - Reviews, analyzes, interprets, and summarizes post market data - Facilitate collaboration with Engineering to support risk management and develop analytical methods for failure analysis. - Collaborate with different cross-functional teams to ensure thorough investigation of complaints. - Apply knowledge of product surveillance data and internal processes to identify potential data entry errors in reports and coordinate updates with system owners. - Uses statistical analysis and investigation techniques to advise Quality Management System processes associated with corrective or preventive actions and risk analysis.

Education & Experience

Education & Experience BS/MS degree in Engineering, Math, Statistics, science-related field, or equivalent technical experience

Additional Requirements

Additional Requirements

• - Excellent project management skills
• - Excellent verbal and written communication skills with ability to lead meetings
• - Strong organizational, time management, and influence skills
• - Experience with risk management is highly preferred
• - Direct experience with receiving, evaluating, and investigating complaints
• - Built or assisted in developing post market strategy for new product introduction
• - Experience in working on software products within a quality or regulatory system