Roles and Responsibilities

• Manufacturing engineering tasks that do not require 4 year degree. Primarily tactical responsibilities. This does not include general administrative work.

• Developing in-depth knowledge of a technical discipline. Uses prior experience and acquired technical expertise to execute policy/strategy.

• In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

• Uses some level of judgment and has ability to propose different solutions outside of set parameters but with guidance. Uses prior experience and on-the-job training to solve straightforward tasks. Has access to technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

• A job at this level is likely to be an individual contributor with proven interpersonal skills or an early people leader who can hire and develop talent. Provides informal guidance to new team members

• Ensure medical devices meet the highest standards of safety, efficacy, and regulatory compliance.

  Lead quality strategy across the product lifecycle, from development through commercialization and post-market surveillance.

  Collaborates closely with cross-functional teams including Eng. manufacturing, regulatory affairs.

  Responsible for defining and maintaining product-specific quality plans, overseeing risk management activities such as FMEA, and ensuring robust control strategies are in place.

  Additionally, to lead investigations into non-conformances, drive corrective and preventive actions (CAPA), and ensure readiness for regulatory inspections and audits.

  A key part of their role is to foster a culture of quality and continuous improvement, using data-driven insights and quality metrics to guide decision-making. They also serve as the quality voice in regulatory submissions, ensuring alignment with global standards such as ISO 13485 and FDA QSR. Ultimately, ensures that patient safety and product integrity are upheld at every stage of the product journey.

Required Qualifications

• This role requires advanced experience in the Manufacturing & Manufacturing Engineering Specialist.

• Knowledge level is comparable to a Bachelor's degree from an accredited university or college with at least 9 plus years of experience.

Desired Characteristics

• Good oral and written communication skills.

• Demonstrated ability to analyze and resolve problems.

• Ability to document, plan, market, and execute programs.

• Established project management skills.