About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO’s technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com. Job summaryThe Senior Director, Mechanical Engineering plans, oversees, and directs all aspects of Mechanical Engineering activities related to medical device product development and technology transfer to Production in support of clinical trials and commercial launch.
The position develops, validates and supports the transfer of device development. Incudes early production of electroporation devices and sterile disposables with associated packaging. The position ensures all mechanical engineering projects, initiatives, and processes are in conformance with INOVIO’s established policies, objectives, and timelines. The position interacts and collaborates with other functional units, such as Electrical and Software Engineering, Manufacturing Operations, Quality Assurance & Control, Regulatory, R&D, Clinical Operations and others. The Senior Director will interact with individuals at varying position levels across the company, including senior level executives, outside vendors and contractors.
The Sr. Dir. is responsible for leading, coaching, and developing a team of Mechanical Engineering personnel.Essential job functions and duties
- Provide engineering leadership to the Mechanical Engineering team and cross-functionally in the creation and implementation of approaches for new product development, sustaining and enhancement of existing products.
- Plan and direct engineering strategies programs to support the business goals and objectives and manage product life cycle.
- Manage mechanical programs for development and support of new devices and associated disposables.
- Prototype multiple design concepts and perform early screening testing to de-risk programs. Develop test methods and equipment as necessary to execute.
- Oversee the process to investigate issues and develop and implement appropriate solutions.
- Focuses on working with R&D early device development activities in support of next generation programs.
- Lead program management at systems level for Mechanical, Electrical, Electromechanical and Software aspects.
- Lead early production sustaining support and future enhancements of existing product lines.
- Identify and address gaps between future strategic objectives of the organization and current engineering capabilities, competencies and skills.
- Provide input to develop and effectively manage the department budget, in partnership with Finance.
- Drive good design practice and discipline in product development.
- Develop new concepts and aggressively pursue patent protection. Review Patents with the Legal department.
- Develop contracts with new outside vendors and manage relationships.
- Review and sign off design, Quality, Regulatory and Production documents: change orders, drawing, protocols and reports, NCMRs, CAPAs, investigations and complaints related to projects.
- Partner with Regulatory on a FDA submission path.
- Write and review SOP’s related to development and production efforts. Review manufacturing material purchase and assembly work instructions.
- Act as liaison for engineering for audits by outside regulatory agencies and funding partners.
- Provide leadership and coaching to other engineers, including evaluating performance, providing feedback, and fostering a culture that promotes development opportunities.
- Complete other engineering duties as assigned
Minimum requirements
- Bachelor's degree with a minimum of 15 years of related experience; or 12 years of experience and a Master’s degree; or equivalent experience.
- Minimum 5 years of management experience in the medical device industry required, with design or development focus for new or next generation devices.
- Entrepreneurial / innovative mind-set, with interest in growing a brand and organization.
- Generation of product development documentation: requirements, plans, specifications & drawings, procedures (test, manufacturing and QC), reports, design reviews and validation
- Injection molding, machined components, fabrication and assembly methods.
- Manufacturing processes and fixture design for reliability.
- Experience with prototyping methods and process.
- Proficiency with FDA regulations and guidelines, cGMPs.
- Experience in ISO13485 regulated Quality system.
- Experience in ISO14971 based Risk Management.
- Proficiency in Human Factors Engineering HE 75 and IEC 62366.
- A wide degree of creativity and latitude is expected.
- Excellent teamwork and leadership skills required.
- Excellent written and verbal communication skills required.
- Proficient with standard Microsoft Office tools and Statistical Software.
INOVIO offers a variety of competitive compensation & benefits to regular full time INOVIO employees including:
- 401(K) retirement plan with Corporate Matching
- Annual Incentives
- Medical, Dental, and Vision
- Generous Paid-time off program and company holidays
- Hybrid work environment (Depending on the nature of your employment with INOVIO)
- Physical, Mental, & Financial Wellness Program
- Company-paid Life Insurance plans
- Long & Short-Term Disability
- Flexible Spending accounts for medical and dependent care expenses
- Employee Discount Perks and so much more…
The annualized base salary range for this role is $229,000 to $279,000 and is bonus eligible. Individual pay decisions ultimately depend on various factors including, but not limited to, relevant experience, knowledge, skills, education, geography, internal equity and alignment with external market data.
Disclaimer
INOVIO Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, INOVIO will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.A current US work authorization is required.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer.
Important notice to employment businesses/agencies
INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.
