The Director, Product Development and Engineering will be responsible for all aspects of the company s engineering product development activities. The Director of Product Development and Engineering will focus on the structuring and operation of the product development engineering function as a cohesive unit; the conceptualizing and day-to-day management of simultaneous projects; delivering manufacturable designs to agreed specifications within time and budget constraints, and the fostering of innovative solutions to customer needs.

Job Summary: Director of Product Development and Engineering

Serve as a key member of the management team that sets the company s strategic direction.

Develop strategic planning for the direction and control of product development activities.

Formulate long-term objectives and standards of performance for the department.

Assure that department achieves objectives and project completion within budget and time frame.

Be a student of current industry trends, ensuring that the company maintains and expands its technology leadership position.

Motivate staff and provide technical direction and guidance, as well as hands-on project management, recognizing the role as that of both manager and support resource.

Assure that product is designed for specific needs, but with wider applications in mind.

Hire and direct staff of senior group members to acquire necessary resources to meet scheduled commitments.

Ensure implementation and refinement as required of formal process to support the product development process.

Ensure that product development is focused on meeting the customer requirements.

Ensure that personal actions, and the actions of employees supervised, comply with the policies, regulations and laws applicable to the business.

Develop and contribute to operating and capital budgets discussions, and control expenditures within approved budget objectives.

Participate in the interview and selection of new employees, team development, performance evaluations, employee concerns and conflict resolution as well as corrective actions and/or terminations.

Collaborate on decisions regarding outsourcing, creating efficiencies and decreasing product costs for the Company while simultaneously protecting Galen s intellectual property.

Champion the Company s culture with an emphasis on team building, empowerment, accountability, creativity, achievement and speed.

Proactively support Company goals and objectives, policies and procedures, the Quality System Regulation, ISO/MDD regulations, and other regulatory requirements.

Maintain a professional and credible image with key physicians, consultants, suppliers, and co-worker

Essential Functions:

Ensure all activities conform to FDA requirements for GMP/QSR and ISO13485.

Support a work environment of continuous improvement that supports Galen s Quality Policy, Quality System and the appropriate regulations for the area supported.

Provide direction for improving the customer experience.

Education Requirements :

Minimum BSSE, 8-10 years of industry engineering experience, with at least 2 years in a management position

Experience Requirements :

Minimum 3 plus years related experience in the medical device industry in addition to at least 2 years of experience in a management position.

Skills/Qualifications/Competencies:

Demonstrated team building and leadership skills.

Ability to think outside the box and come up with creative solutions to advance and support our solutions.

Competent in electronic hardware and software design.

Ability to manage diverse, simultaneous projects of varying complexities.

Strong relationship, management, strategy development, project management, problem-solving skills and change management skills.

Professional and positive approach, self-motivated, team player, creative with the ability to work on own initiative.

Demonstrated strong oral and written communication skills.

Proven leadership capabilities including strategy development, effective decision making, and the ability to drive results.

Self-motivated, self-directed, and able to thrive in a fast-paced environment.

Ability to translate and articulate complicated business problems into easily understood solutions and functional requirements.

Ability to work cross-functionally with a distributed team across Engineering, Design, Customer Success, Marketing and Business Development.

Physical Factors:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Working Conditions:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Unplanned Activities:

Other duties as assigned

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