Design Quality Engineer bei NeedleTech Products Inc.
NeedleTech Products Inc. · North Attleboro, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Optionales Büro in North Attleboro
The Design Quality Engineer at NeedleTech Products Inc. is a strategic and hands-on role responsible for driving quality and regulatory compliance throughout the product development lifecycle. This position is ideal for an experienced engineering professional with a strong background in design controls, risk management, and quality assurance within the medical device industry. The successful candidate will lead client-facing projects, collaborate across departments, and ensure products meet FDA and ISO standards. This role offers the opportunity to champion quality initiatives, drive continuous improvement, and shape the future of product reliability and safety at NeedleTech.
Responsibilities
- Leads product development projects with a focus on design controls, risk management, and regulatory compliance.
- Manage client interactions and project execution from planning to delivery.
- Initiate and drive risk management activities (FMEA, fault tree analysis, ISO 14971).
- Ensure compliance with design control and quality standards, including FDA (21 CFR 820), ISO 13485, and ISO 14971.
- Review and approve design documentation (DHF, RMF).
- Collaborate across R&D, regulatory, quality and manufacturing teams.
- Support design reviews and validation processes.
- Monitor regulatory updates and revise internal procedures as needed.
- Conduct audits and inspections of design processes and procedures.
- Champion continuous improvement initiatives within the design department.
- Mentor and coach junior engineers and technicians.
- Manage complaint systems and post-release safety risks.
- Develop and implement quality control plans and risk management processes.
- Facilitate usability analysis and activities in accordance with IEC 62366.
Key Qualifications
- Bachelors in Bioengineering, Biomedical, Mechanical Engineering, or a related field is required. Master’s degree is preferred
- Minimum 5 years of experience with direct client interactions, product demonstrations.
- Minimum 5 years of experience in design controls, risk management, and quality engineering.
- Proficiency in CAD software and statistical analysis tools.
- Strong knowledge of regulatory requirements (FDA, ISO 13485, ISO 14971).
- Experience with CAPA systems, audits, and validation requirements.
- Expertise in design verification and validation methodologies.
- Familiarity with quality management systems (QMS) and failure analysis techniques.
- Knowledge of Design for Manufacturing and Assembly (DFMA) principles.
Technical Competencies
- Quality control standards and methodologies.
- Quality assurance software and tools.
- Design control principles and risk management.
- Statistical process control (SPC) methods.
- Problem-solving methodologies (Six Sigma, Lean).
- Usability engineering and design reviews.
Soft Skills
- Strong analytical and problem-solving abilities.
- Excellent communication and documentation skills.
- Attention to detail and accuracy.
- Ability to work effectively in cross-functional teams.
- Organizational and time management skills.
- Adaptability and flexibility in handling changing priorities.
- Critical thinking and decision-making abilities.
- Initiative and independence.
- Leadership and teamwork.
- Continuous learning mindset.
Managerial Competencies
- Leadership and team/peer management.
- Policy and procedure development.
- Project management and regulatory standards knowledge.
- Analytical skills for interpreting quality data and making informed decisions.
Work Environment
- Typical office environment with use of various office equipment. Full-cycle production environment in manufacturing surgical medical products, including specialized manufacturing equipment, chemical cleaning/sterilization for producing specific customer product.
Physical Requirements
- Function of position requires work throughout various departments within the facility, customer meetings in a sedentary environment, as well as demonstration of product within a production environment.
- Lifting and moving of product, equipment typical to validation and quality control measurements, office equipment up to 20 pounds.
- Hand to eye coordination within the processes of quality design, including use of computers, phones and various office and quality equipment.
