Senior Design Quality Engineer

Purpose

The Global Lead - Design Quality Assurance will be a multi-site leader and oversee engineering support required for all new product development and lifecycle management projects. This position will support a global deployment of Design Controls procedures and is responsible for ensuring projects are adequately staffed to achieve required milestones. This individual will collaborate and partner with peers and senior leadership in other organizations, including Research & Development, Regulatory, Marketing, Supply Chain and Manufacturing Operations. This role will also be required to support other aspects of the QMS, including Quality Systems, Post Market Surveillance and Supplier Quality.

Key Responsibilities

• Lead Design Assurance teams across multiple sites on product development and sustaining engineering projects of major magnitude and scope. Provide guidance and training to staff, help identify and achieve career goals, motivate individuals to achieve results and recruit/maintain a high-quality staff.
• Derive and implement department strategies; seek innovative approaches to attaining product performance goals.
• Develop, deploy and maintain state-of-the-art Design Controls and Risk Management procedures. Provide the necessary training and support to increase global understanding of requirements to achieve compliance.
• Collaborate with other leaders in the Quality organization to drive maturation of QMS procedures. Provide support during Audits, Complaint Review Boards, CAPA Review Boards, etc.
• Establish and maintain positive cross-functional working relationships to help further advance the Quality culture and drive Quality as an advantage
• Provide significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.
• EU MDR remediation support
• Responsible for risk management planning, use/design failure mode effects analysis (FMEA), risk control and mitigation and verification of effectiveness.
• Responsible for quality design transfer activities including test method validation / measurement systems analysis and incoming inspection. Support other design transfer activities, including process validations, master validation plans, process summaries, and process failure mode effects analysis (FMEA).
• Responsible for development and release of engineering design documentation, support core team during design reviews and support design history file compilation/audit activities.
• Provide quality input to product user needs, design inputs, design specifications and design outputs (including analysis/definition of critical to quality features).
• Support design verification testing, design validation and usability testing.
• Assists in preparation for regulatory submissions and support sustaining quality with defending design control elements during internal and external audits. Includes leading design control gap assessments (DHF audits).
• Assist in identification and implementation of process improvement initiatives which require cross-functional and multi-site collaboration.
• This role will also be required to support other aspects of the QMS, including Quality Systems, Post Market Surveillance and Supplier Quality.
  
  

Qualification

Required Knowledge, Skills And Abilities

• In depth familiarity with the FDA, ISO, MDD/MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
• Detailed understanding and working knowledge of US and International regulations including 21CFR820, 803, 50, and 11 is required, as well as the Medical Device Directive/ Medical Device Regulation, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366.
• Strong communication and presentation skills.
• Competent with use of Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent).
  
  

Minimum Required Education And Experience

• 8+ years of medical device engineering experience
• 1+ years of leading engineering teams
• BS in Mechanical, Electrical, or Biomedical Engineering
  
  

Physical Requirements

• Sitting for long periods of time
• Typing
• Standing
• Squatting
• Lifting up to 20lbs unassisted
  
  

Company

BVI® is refocusing the future of vision.

As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.

We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at www.bvimedical.com