Hyalex Orthopaedics is an award winning, venture funded medical device start-up developing transformational synthetic cartilage technology and implant systems for diseased and damaged joints. We address unmet clinical needs to improve patient quality of life so that we all can Be Active and Stay Active. Our Hyalex team is comprised of industry leaders, innovators, and experts who have developed and launched many successful commercial products as well as a team of brilliant engineers, scientists and medical professionals.
The Manufacturing Manager will be responsible for all functions as the manufacturing lead in areas such as process optimization, transfer of new products, cost improvements, facility maintenance, safety and environmental regulations. This is a hands-on position in the Hyalex Orthopaedics laboratories and cleanroom and requires excellent attention to detail. The role will have a close working relationships with all members of Research and Development including the VP of R&D, Design, Process Engineering as well as Quality and Finance. Maintains relationship with key external stakeholder including suppliers and service providers and will report to the VP of Technical Operations..
Role and Responsibilities
- Lead and participate in the development of new manufacturing product line(s) in cleanroom operations.
- Support failure investigation, qualifications, and validations (IQ, OQ, PQ’s) of processes and/or equipment.
- Manage manufacturing supply of product to meet internal and external customer demand.
- Maintain manufacturing schedule.
- Manage materials, inventory and BOM’s
- Select, qualify, and manage vendors for the procurement of production equipment or production materials.
- Leadership role in safety and environmental programs.
- Maintain compliance of operations with all local, state and federal requirements as well as with quality management system requirements.
- Manage the capital equipment budget and asset acquisition process to support operations.
- Provide input to facility planning and expansion plans
- Author and maintain documents in accordance with regulatory and quality system requirements including manufacturing and production records.
- Own manufacturing documentation such as Work Instructions for all processes.
- May supervise and train junior level scientists, engineers, technicians, and co-ops.
- Providing proof of full COVID-19 vaccination status. While the Company will consider accommodations for disability- and religious- based reasons, vaccination is generally considered a necessary attribute of the position.
- Other duties as may be assigned
- Bachelor’s degree in an engineering discipline or equivalent. Chemical or Polymer Engineering preferred
- Minimum of 5 years of experience in manufacturing technical operations, specifically cleanroom operations
- Positive, energetic, self-motivated
- Extensive knowledge of GMP and FDA regulatory requirements for drugs and / or devices required
- Experience working with PMA and/or class III medical devices preferred.
- Lean manufacturing experience preferred.
- Strong verbal and written communication skills
- Experience generating and releasing quality-controlled documents such as IQ/OQ/PQ, test method validations, and component qualifications.
- Reliable self-starter who collaborates and leads fellow team members to accomplish tasks and meet deadlines.
- Experience in leading and coordinating technical staff desirable.
- Experience in safety and environmental program development and leadership desirable.
- Experience training personnel on manufacturing procedures.
- Machine shop experience and CAD experience in Solidworks a plus.
Hyalex values are focused on teamwork, communication, innovation, integrity, and accountability and all team members strive to promote an inspirational and productive workplace. Every team member’s contribution is valued as we work towards a common goal of transforming orthopaedics.
What we offer:
- Competitive compensation and generous stock options
- Comprehensive medical, dental and vision benefits
- Pre-tax savings plans for healthcare
- 401(k) retirement plan
- Generous paid time off (PTO)
- Short-term and long-term disability insurance and an employee assistance program
- Life and AD&D insurance
- Tuition reimbursement
- Paid parental leave
- The opportunity to work with driven and enthusiastic colleagues in a fast-paced and entrepreneurial environment, on problems that matter in a highly collaborative environment
Important notice to Employment businesses/ Agencies
Hyalex does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact the Hyalex human resources department to obtain prior written authorization before referring any candidates. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Hyalex. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Hyalex. Hyalex shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.