Program Management Specialist

2 weeks ago

West Boylston, Massachusetts, United States Coghlin Companies Full time
Job OverviewPosition Summary:

The Engineering Program Manager is responsible for ensuring the success of programs throughout the entire customer engagement life-cycle. This includes defining requirements, managing proposals, negotiating contracts, and overseeing the execution of product development plans. The role also involves validation and qualification testing, ensuring final acceptance, and adhering to the design control process while complying with the Cogmedix Quality System, 21 CFR 820, and ISO standards. Success in this role is measured through business metrics, audit outcomes, and customer satisfaction.

The Engineering Program Manager will oversee multiple programs, which may consist of various projects depending on their size and complexity. This position is key in maintaining both customer and internal dashboards and managing the time and audit of engineering staff.


Key Responsibilities:
  • Manage multiple programs for one or several customers, ensuring effective resource allocation and process management.
  • Mentor and guide teams in design, prototyping, documentation, and validation services to facilitate initial product launches.
  • Act as the primary liaison with customers, fostering strong relationships with key stakeholders to enhance customer satisfaction and explore strategic business opportunities.
  • Provide regular updates on program status to customers and senior management, highlighting key milestones, challenges, risks, and mitigation strategies.
  • Maintain project information in PLM and ERP systems, ensuring accuracy and timeliness.
  • Deliver financial updates on Engineering Services programs and present concise program status reports to senior management.
  • Oversee program performance, including design control processes, schedules, milestones, and materials management strategies.
  • Manage change processes with customers to ensure timely coverage for additional efforts and communicate impacts effectively.
  • Coordinate with other project managers, engineers, and senior management to identify resource needs and resolve conflicts.
  • Support business growth by identifying new engineering opportunities and collaborating with various departments.
  • Lead phase closeout reviews to analyze delivery against plans and recommend improvements for future phases.

Essential Qualifications:
  • Strong commitment to compliance and quality standards.
  • Positive attitude, self-motivated, with excellent organizational skills.
  • Exceptional customer service and communication abilities.
  • Bachelor's degree in engineering or a related field; relevant professional experience may substitute for educational requirements.
  • Minimum of 5 years in Project or Program Management preferred.
  • Experience in engineering, manufacturing, supply chain, or quality engineering within the medical device industry is highly valued.
  • Familiarity with ISO 13485 and FDA cGMP environments is essential.
  • Design Control experience is required.
  • 3+ years of experience with FDA-regulated medical device engineering is preferred.
  • Strong interpersonal skills and the ability to establish rapport with internal teams and customers.
  • Proficient in Microsoft Office Suite and experience with ERP and PLM systems is advantageous.
  • Willingness to travel occasionally and perform duties outside of a typical office environment.

Cogmedix is an Equal Opportunity Employer, committed to diversity and inclusion in the workplace.

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