Sr Quality Engineer – Medical Device

Job Title:
Sr Quality Engineer – Medical Device

Job Location:
Lafayette, Colorado (Fully Onsite)

Type: W2 contract

Job Description:

As a design quality engineer, you will work with a cross-functional team to develop new products or new features on existing products for the Acute Care & Monitoring business.

You will review user and system requirements, design documentation, test plans, test protocols, test reports, and deliverables per the development procedures.

You will work cross-functionally to review FMEAs and security evaluations and transfer those risks into risk management files for the product under development.

Must Have:

Medical device design, development & manufacturing, and manufacturing experience with products with electrical functionality is an advantage.

Examples of critical thinking and proven project execution.

Leading a cross-functional team and leveraging solid PM skills, e.g., project planning, communication, risk management, etc. Work collaboratively and with respect & humility with a cross-functional team to drive project execution for medical devices, prioritizing safety, quality service, and on-time execution.

Lead team to define goals, provide solutions, and align on path forward, drive/track/communicate progress, and adapt as needed with the team. Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures. Use scientific problem-solving methodology,s e.g., DMAIC, process map, 5 whys, Is/Is not, etc. Drive solid decision-making.

Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance). Understand priorities, drive the critical path, monitor secondary critical paths for progress, and communicate early any challenges.

Education Required: Bachelor’s degree in an engineering discipline, Years’ Experience

Required:

Up to 8 years.

Nice To Have:

2+ years of Product development experience, Intimate knowledge of Risk Management

Technical skills required for the role:

1. Understanding of systems engineering – requirements flow from user needs to system requirements to subsystem requirements.

2. Understanding of Risk Management standard: ISO 14971 and how to apply it to hardware and software (IEC TR 80002-1).

3. Familiarity with medical devices standards for electrical safety (IEC 60601), software (IEC 62304), and biocompatibility/sterilization (ISO 10993).

Responsibilities may include the following, and other duties may be assigned:

Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials products. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment;

conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.

Specialist Career Stream:
Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop an approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects/processes. Organizational Impact:
May be responsible for entire projects or processes within the job area. Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments. Innovation and Complexity:
Problems and issues faced are difficult and may require an understanding of multiple issues, job areas, or specialties. Makes improvements to processes, systems, or products to enhance performance of the job area. The analysis provided is in-depth in nature and often provides recommendations on process…