We are currently searching for a skilled professional to join a well-known client's team as a Senior Project Engineer - Manufacturing in Durham, North Carolina. This role will prepare and implement an improvement plan for areas of responsibility relating to: future machine and equipment needs (related to growth and replacement), preventive maintenance needs, new product support, and general process-related improvements. If you are a career-focused professional, this is the role for you.
RESPONSIBILITIES
Maintain an understanding of new methods, equipment, product specifications, waste, costs, through put rate, and material costs
Justify new equipment and cost-reduction projects with technical data
Document all equipment, machines, and tooling with accurate and clear detailed prints and maintenance instructions
Prepare, direct, or approve the preparation of all engineering product and process specifications/changes
Contribute technical guidance to manufacturing and hourly technical personnel during the start-up of new or changed products/processes
Obtain quotes, investigate vendors, and plan budgeting/scheduling for procurement of capital equipment
Oversee the redesign of existing equipment to incorporate improvements relating to safety, machine reliability, product quality, and/or cost reduction
Coordinate design activity with outside vendors, internal departments, or self-design drafts to implement improvements
Provide concepts and supporting data for cost-reduction proposals to meet the plant's productivity objectives
Initiate cost improvement projects, manage budget, and write large CB-2s
Supervise and evaluate job duties and performance of hourly associates in areas of technical expertise
EXPERIENCE
Minimum of 5 years of related engineering experience required
Management experience required
Experience leading engineering projects related to productivity improvement, cost savings, capacity expansion, or new process development
Knowledge of cGMP, FDA regulations, and/or medical device manufacturing experience
Excellent leadership skills
Good decision-making, problem-solving, and trouble-shooting techniques
Travel required - up to 20%
EDUCATION
Minimum of Bachelor's Degree in Science, Mechanical Engineering, or a related engineering field required
Associate's Degree in a related engineering discipline with greater than 8 years of experience considered
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.