Job Title: Director of EngineeringJob Description We are seeking a Director of Engineering to lead our Integration and Sustaining teams. This role involves directing design transfer and scale-up activities, ensuring compliant and effective post-launch processes, and establishing strong working relationships with stakeholders. The Director will use a metrics-based approach to update company leadership on progress and challenges, monitor project performance, and develop relationships with key customers to resolve technical issues. Responsibilities + Direct the work of the Integration team to effectively execute on design transfer and scale-up activities, including process qualifications and transfer to Manufacturing and Supply Chain operations. + Communicate the status of ongoing efforts. + Direct the work of the Sustaining team in partnership with Facilities Engineering and Quality to ensure compliant, effective post-launch processes and products. + Execute CAPA tasks and yield improvement or other cost optimization projects. + Communicate status and challenges across functions. + Establish effective working relationships with internal and external stakeholders with strong emphasis on clear and effective communication. + Ensure that all appropriate technical documentation, drawings, and specifications are generated in compliance with procedures, statutory requirements, and applicable standards. + Use a metrics-based approach, including dashboards or visual tools, to routinely update company leadership on progress and challenges. + Present recommendations for action where challenges occur. + Monitor project and ongoing work performance, measure timeliness and future risk, and provide guidance to project resources. + Escalate issues or support resources experiencing challenges to proactively assure successful outcomes. + Develop relationships with key customers to understand and resolve technical issues arising during new product introduction and scale-up. Essential Skills + Experience in medical device industry and scale-up manufacturing operations. + Qualification and validation – process characterization. + Experience in process development, GMP, engineering, operations management, process improvement, and continuous improvement. + Experience with validation processes. Additional Skills & Qualifications + Master’s Degree in a scientific or engineering discipline, with a preference for collagen and/or tissue science. + 10+ years of experience in the medical device or related industry. + 5+ years of experience in a senior decision-making role. + Excellent interpersonal and communication skills. + Collaborative leadership skills. + Experience with MS Project software. + Understanding of ISO and FDA guidelines as they apply to operational quality, GMP, and validation. + Excellent organization and time management skills. + Ability to thrive in an ambiguous and fast-paced environment, operating at both strategic and tactical levels. Work Environment The Director of Engineering will be part of the Core Leadership Team at a global level, overseeing a team of 7-8 engineers. The team includes both new and experienced engineers who require development and support. This role offers the opportunity to lead and grow within a constantly active and project-driven environment. The company is privately held and provides great benefits, including medical benefits starting on the first day, a 401k plan requiring no employee contribution, and frequent employee activities. Pay and Benefits The pay range for this position is $160000.00 - $200000.00 • PTO: 19 days/year• Holidays: 9 recognized holidays/year• Medical Plan• Pharmacy• Cigna Resources• Dental• Vision Workplace Type This is a fully onsite position in Oakland,NJ. Application Deadline This position will be accepting applications until Feb 4, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.