Director - R&D for Drug Delivery and Implants

Director - R&D for Drug Delivery and Implants

Job Category : Research & Development Requisition Number : DIREC001111 Showing 1 location Job Details

Description

I. PURPOSE OF JOB :

With an extensive background and experience in medical devices, Director, R&D leads a strong team of development engineers and makes business & product development critical strategy decisions.

Director, R&D is responsible for driving innovation, strategy, vision and performance for the Company. This role provides l eadership and management of a strong engineering teams and external partners focused on product development in multiple cross functional areas such as mechanical engineering, design for manufacturability and pre-clinical research.

This role also has an in-depth knowledge of the clinical procedures, quality management systems for product development and regulatory support for combined drug device products.

Product development experience with drug delivery systems, drug coatings, bioabsorbable materials and nitinol are strongly desirable.

II. MAJOR DUTIES AND RESPONSIBILITIES :

• Develop and lead teams to develop standards and procedures to ensure technologically sound, timely and cost effective delivery of products and features.
• Understand and collaborate on complete product lifecycle from design concept to design transfer.
• Responsible for ensuring that the product vision is realized through execution of design control process for implant designs and drug delivery systems.
• Develop and maintain a technical roadmap that will continue to innovate from a technical standpoint.
• Work closely with the management team to develop and manage the engineering roadmap.
• Track roadmap to ensure quick time-to-market delivery with optimal resources.
• Design and develop new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost.

Solve complex problems at the product level.

• Direct and encourage the development team to utilizing DOE methodology and other experimental design tools. Generate effective testing reports.
• Facilitate performance & safety studies.
• Formal supervision of technicians and engineers.
• Guide structure and content of design review meetings.
• Complete projects (including product enhancements) in an aggressive manner consistent with corporate objectives. Independently determine day-to-day tasks.
• Maintain contact with and gather feedback from key physicians involved in Sight Sciences product development programs.
• Contribute to the intellectual property position of the company via invention and patent applications. Maintain accurate documentation of concepts, designs, drawings, and processes.
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to Sight Sciences products.
• Provide engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.
• Engage and oversee outside vendors and consultants as required.
• Operate with GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions. Provide support in the resolution of product complaints and / or safety issues.
• Work with the Manufacturing, Clinical Affairs, Sales and Marketing, and Quality Assurance functions to coordinate pilot production of new products.
• Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, ISO 14971, ISO 11607, and any other applicable domestic or international requirements.
• Maintain a professional, credible image with key physicians, consultants, vendors, and co-workers.
• Perform other duties as assigned.

III. PREFERRED SKILLS :

• Expert knowledge of SolidWorks.
• Working knowledge of the patent process.
• Ability to generate written reports of extreme complexity.
• Ability to perform computerized project scheduling.
• Strong background in statistical methods.
• Strong background with injection molding component designs.
• Strong background with adhesive bonds processes.
• Strong background with terminally sterile product and packaging design.
• Strong background with design control processes for implant designs and preclinical implant testing.
• Strong background with drug delivery systems and experience working with pharmaceutical suppliers or contract manufacturers.
• Background 510k (Class II) and PMA (Class III) regulatory pathways, 21 CFR 211.
• Experience within ophthalmic medical device industry.

IV. EDUCATION REQUIREMENTS :

At minimum a bachelors of science degree within mechanical engineering, biomedical engineering or equivalent experience.

V. EXPERIENCE REQUIREMENTS :

• BSME or equivalent and 12 - 15 years or MS and 10 - 12 years experience preferred.
• Expert knowledge of patent process.
• Experience in the medical device industry is also required.

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Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)