Engineering Project Manager
5 days ago
Skaneateles Falls
Job Description Job Title : Engineering Project Manager III Hybrid: Required to be onsite 3 times per week. Location : Skaneateles NY 13153 Duration : 12 months Job Summary: Lead cross-functional teams in complex engineering assignments, ensuring compliance with medical device regulations and effective project execution. This role requires a strong focus on project management, collaboration, and problem-solving across traditional product lines. Primary Responsibilities • Independently plan, execute, and direct cross-functional engineering projects, adapting standard engineering principles to develop innovative solutions., • Manage projects consisting of cross-functional teams (including but not limited to regulatory, risk management, quality, technical communications, and supplier quality), • Oversee all financial aspects of product development, including capital expenditures and cross-functional expenses., • Identify and resolve complex problems, developing new solutions as needed for project roadblocks. Knowledge • Medical Device Regulations: In-depth understanding of FDA regulations, ISO standards, and other relevant guidelines governing medical device labeling and compliance., • Project Management Methodologies: Familiarity with project management frameworks (e.g., Agile, Waterfall) and tools (e.g., Gantt charts, project management software)., • Engineering Principles: Strong foundation in engineering principles relevant to medical device design and development., • Quality Management Systems (QMS): Knowledge of QMS practices and documentation requirements., • Cross-Functional Team Dynamics: Understanding of the roles and responsibilities of various departments involved in medical device development. Skills • Project Management Skills: Proven ability to manage multiple projects simultaneously, ensuring timely delivery within budget., • Analytical Skills: Strong analytical and problem-solving skills to identify issues and develop effective solutions., • Communication Skills: Excellent verbal and written communication skills for diverse audiences., • Leadership Skills: Ability to lead and motivate cross-functional teams., • Attention to Detail: Meticulous attention to detail in reviewing labeling documentation. Abilities • Independent Judgment: Ability to make informed decisions in evaluating engineering techniques., • Adaptability: Flexibility to adapt to changing project requirements and industry trends., • Time Management: Strong organizational skills with effective prioritization., • Interpersonal Skills: Ability to build and maintain positive working relationships., • Continuous Learning: Commitment to staying current with industry developments. Qualifications • Bachelor’s degree in Engineering or a related field., • 8-10 years of relevant experience in project management, with a focus on medical devices., • 2-5 years of experience in matrix management., • Thorough, up-to-date knowledge of multiple engineering disciplines. Responsibilities: • Identify key project members and milestones required to the project (Project Scoping)., • Work cross functionally with internal and external parties (R&D, Technical Communications, Suppliers, etc.)., • Provide updates on project status on a weekly basis., • Execute projects to closure in a timely manner., • Ensure that output meets the project intent once closed., • Document all project key decisions and evidence of milestone completions, that the project documentation is auditable and compliant to all Medical Device Industry requirements. Skills: • High Communication Skills Required., • Ability to Negotiate Cross-Functionally., • Self-Starter, Driven., • Ability to Work Independently., • Strong attention to detail., • Proven Track Record to Complete Projects., • Ability to use Microsoft Office. Education & Experience: • Minimum of a bachelor’s degree, • 8 – 10 years of experience in Manufacturing/Operations and/or Project Lead 2 - 5 years of matrix mgt., • PMP Certification is preferred., • Regulated Industry experience preferred., • Experience working on projects related to labeling updates is preferred., • Experience in Trackwise, SAP, preferred. Good communication skills with matrix management experience required. Independent judgment in the evaluation, selection and adaptation of various engineering techniques required. Company DescriptionSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs. Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilitiesSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.\r\n\r\nBased in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities