Ashland, MA, United States
$110,000 - $130,000
3 months ago
This is a chance to join a company that has seen fantastic growth over the past few years in their Medical Device manufacturing business unit, accelerated exponentially the past few months due to their reputation in the market as trustworthy partners in manufacturing COVID-19 diagnostic testing kits.
In this role you will be responsible for leading a highly effective engineering team of 6 in support of their GxP manufacturing responsibilities by:
- Establishing and maintaining engineering policies, procedures and other documentation as appropriate
- Leading the engineering team in reducing the time, costs, and risks to carry out new business requirements.
- Collaborating with the company’s compliance organization to ensure regulatory standards are met at all times.
- Coordinating the design and validation of new equipment, product, and processes
- Leading activities for creation of engineering studies, product specifications, quality plans, manufacturing methods, work instructions, risk assessments, and other quality documentation
- Ensuring the efficient and effective release of new programs to manufacturing once development is complete
- Effectively managing multiple complex projects, stay organized, meet cost and time budgets, and drive to completion
- Supervising the engineering team including process engineers, mechanical design engineers, and other similar roles
- Bachelor’s degree in engineering or other technical discipline
- Minimum of 5-10 years’ experience in a regulated market such as medical device (particularly IVD), pharmaceutical, biologics, or combination device with 10 or more years’ experience preferred
- Experience managing a team of engineers or other technical staff with a demonstrated ability to drive results and develop personnel.
- Experience validating equipment, software, product, and processes within the Quality System Regulation (QSR) framework, including 21 CFR Part 11 compliance.
- Familiarity with the validation lifecycle and risk management (ISO14971) critical
- Experience developing cost models for unit cost, capital, and development (non-recurring) costs
- Experience at a contract manufacturing organization a strong plus
- Experience and aptitude with technical software such as Minitab, CAD, and the like preferred
This is a FTE salaried opportunity with a base salary range of $110,000 - $130,000 + employee shares & benefits.You must be a US Citizen or Permanent Resident Holder to apply for this position, unfortunately no sponsorships are available.