Summary

Apple is where individual imaginations gather together, committing to the values that lead to great work. Every new product we build, service we create, or Apple Store experience we deliver is the result of us making each other’s ideas stronger. That happens because every one of us shares a belief that we can make something wonderful and share it with the world, changing lives for the better. It’s the diversity of our people and their thinking that inspires the innovation that runs through everything we do. When we bring everybody in, we can do the best work of our lives. Here, you’ll do more than join something — you’ll add something.

Our ever-evolving suite of Heath and Wellness products for 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 commitment to leave the world better than we found it.

The  Health group is looking for a Head of Technical Management / Manufacturing to support medical software maintenance and release in China for regulated features. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient organization who works closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands.

Description

The Head of Technical Management / Manufacturing is part of the production quality team supporting Apple’s medical products. The team is responsible for working closely with Engineering, Project management, and Post-Market surveillance teams to ensure product conforms to specified requirements.

This role is critical in driving product and process issue resolution, maintaining the design history file, performing risk assessments, release management and ensuring clear communication / timely progress reporting across teams.

Responsibilities

• Ensure that products meet Quality goals, and regulatory requirements
• Ensure design controls and manufacturing efforts are executed in accordance with established procedures and other documents;
• Ensure that all records are truthful, accurate, complete, timely, and traceable;
• Organize the maintenance of premises and facilities and equipment to ensure they remain in good operating condition (as applicable);
• Ensure that employees responsible for design and manufacture receive training and possess the knowledge appropriate to their positions;
• Work with cross functional teams such as clinical, engineering and post market surveillance groups to ensure product investigations are completed (as applicable).
• Maintain design control and risk management documentation
• Responsible for product release activities
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving Quality issues to continuously improve product safety and performance
• Serve as the Subject Matter Expert to the Company on China GMP related to design / manufacture of software medical devices
• Provide support for other Quality activities and initiatives, quality data collection and trending, internal and external audits, training, authoring procedures, etc.
• Assist in different project work and process improvements as needed
• Be responsible for other activities related to product design and manufacturing
  
  

Minimum Qualifications

• 3+ years of Medical device experience in a Quality/Regulatory role
• Experience interpreting requirements and following standard operating procedures
• Experience with design control and risk management activities for Medical devices, including development and maintenance of design history files
• Education ~ B.S. ME/EE/BME/CS degree or equivalent in any Engineering / Science discipline
• Excellent written and verbal communication skills
• Excellent interpersonal skills working across multiple divisions
• Attention to detail, well organized and time efficient
• Knowledge of domestic medical device regulatory requirements (China GMP), ISO13485, ISO 14971, IEC 62366, IEC 62304 and other applicable regulations
• Proficient in English both oral and written
• Experience leading and managing regulatory audits
  
  

Preferred Qualifications

• Experience working on software medical device products within a Quality or regulatory system.
• Expertise in execution of design controls for software as a medical device.
• Experience in managing, maintaining and implementing quality management systems
• Proven background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight.
• Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes.
• Strong organizational and leadership skills.
• Excellent communication skills, both verbal and written. Ability to take initiative in an ambiguous and fast fast paced environment
• Excellent verbal and written communication skills with ability to lead meetings
• Strong organizational, time management, and influence skills
• Knowledge of international medical device regulatory requirements
  
  

Apple is an equal opportunity employer that is committed to inclusion and diversity, and thus we treat all applicants fairly and equally. Apple is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities.