InnFocus, located in Miami, FL with approximately 75 staff members onsite, is a subsidiary of Santen Inc. Santen is a specialized pharmaceutical company focused exclusively on ophthalmology in global markets around the world with more than 4,000 employees and sales in approximately 60 countries. Santen Inc., located in Emeryville, CA (US HQ), contributes important ophthalmic research & development and commercialization efforts, and is home to our regional business teams. This office currently employs about 140 people with large growth plans in the near future.
With the passionate support of our Japanese parent company and its 130-year heritage, Santen is pursuing intellectually-challenging and stimulating work to deliver game-changing therapies that make hope a reality for people facing vision impairment and loss. We are driven by and committed to our mission and we are in search of top talent to help us meet our aggressive and important goals.
This is a leadership position supporting new product introduction and manufacturing process improvements in the areas of polymer manufacturing, extrusion, molding, non-sterile packaging and kitting of the PRESERFLO MicroShunt medical device. Establishes and reviews production processes, standards, and procedures to ensure the highest quality product.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Develop talent that can successfully meet all manufacturing demands, while focusing on exceeding the expectations of both internal and external customers
- Lead the engineering group, team of 4 direct reports, in the transfer of new products from feasibility testing to process development and new product introduction
- Investigate and procure state-of-the-art manufacturing equipment for manufacturing process improvement
- Work with the engineering team in the understanding of risk, tolerance stack up analysis and the interpretation of technical drawings and prints
- Collaborate with QA and R&D on the qualification of current and future suppliers
- Provide technical input for CAPA, NCMR resolution and participate in MRB, as needed
- Actively participates in resource planning to ensure that InnFocus can successfully achieve goals and commitments from internal and external customers
- Partner with HR to hire engineering staff members
- Support internal and external audit
- Participate in internal design review meeting for the completion of the Design History File
- Provide recommendations to senior management for process improvement projects
- Oversee the evaluation of new and existing technologies, methods, materials, equipment and processes
- Lead the engineering team in the areas of mold development and tooling fabrication
- Collaborate with cross-functional managers including Regulatory, Quality, Manufacturing, Clinical and Supply Chain
- Lead the engineering team in statistical and measurement system analysis
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Prior management or supervisory experience required, preferably in a medical device environment
- Excellent communication skills including written, verbal and presentation
- Ability to work effectively in a team environment
- Working knowledge of EN ISO 13485 preferred
- Detailed understanding of medical device manufacturing process validations
- Proficient with Microsoft Office products
- Excellent leadership and time/project management skills
- Lean manufacturing experience
- Desire to foster a team environment driven by a positive and constructive influence
- Excellent organizational skills; documentation
- Hands-on experience writing and executing validation protocols
- Ability to interface with regulatory bodies to present technical information
- Understand basic applied statistics, statistical sampling plans, and statistical process control
- Have knowledge of advance statistical methodologies such as DOE
- Experience in the development and interpretation of SOPs and Work Instructions (WIs)
Bachelor’s Degree in engineering discipline (Biomedical or Mechanical Engineering preferred).
- Minimum of 7 years of experience in engineering/development environments or at least 5 years in the medical device industry with an advanced engineering degree
- Working knowledge of QSR, cGMP, ISO 14971 and ISO 13485
- Hands-on experience in medical device manufacturing