Title:  Engineer, Combination Products & Medical Device-Columbus Ohio

Job Title:      Engineer, Combination Product & Medical Device

Location:      Columbus, Ohio

Job Type:     Full time

Req ID:          6376

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Engineer, Combination Products & Medical Device to join our team.  In this role, you will be responsible for The Combination Products & Medical Device Engineer is responsible for providing Combination Product and Medical Device support and standardization for the Quality System and Design Controls within local operations.  Support includes ensuring that all applicable Combination Product and Medical Device regulations are incorporated within corporate and local procedures and are adequately implemented within the manufacturing site.  Implements required documentation and studies to support requirements for development, launch, lifecycle changes, and Business Development (3P) opportunities to meet identified business objectives and targets.  Work is performed with direction in determining technical objectives from both a short-term and long-term perspective for desired results.

 You will work closely with Research & Development, Technical Services, Operations, Quality Control, Quality Assurance and Hikma global sites.

Key Responsibilities:

Knowledge Management

• Supports the site as a contact with regards to combination products and medical devices and has knowledge of other related disciplines.
• Stays up to date on regulations and regulatory trends to ensure that practices and procedures remain current with regulatory health authorities’ expectations with regards to Combination Products and Medical Devices i.e. 21 CFR Part 820 QSR, 21 CFR Part 4, ISO 13485, ISO14971, etc…
• Supports Combination Product and Medical Device inspection readiness and regulatory inspection responses as needed
• Expands site education with regards to combination products and medical device requirements and organizational processes

Infrastructure Support

• Supports the lifecycle management of the Quality Management System, Processes, and Procedures, to be compliant with all relevant combination product and medical device regulations
• Works within a Combination Product Board to share and align on best practices within local operations.
• Supports Risk Management approach and implementation
• Contributes in relevant Quality Governance meetings

Project Support

• Actively participates on departmental and/or cross-functional teams as Combination Product and Medical Device Subject Matter representative

• Applies technical expertise while supporting the successful completion of project teams.
• Performs gap assessments of processes and procedures against relevant industry / device regulations
• Contributes recommendations and proposals to address technical solutions to problems and interacts with senior personnel on significant matters
• Completes key activities such as risk analysis, FMEA, and hazard analysis for projects
• Supports change control tasks for Combination Product & Medical Device
• Attends and actively participates in Combination Product tactical meetings to support life cycle changes
• Perform updates of Design History Files and support remediation of Design History Files for legacy products
• Provides support for relevant investigations and CAPA(s)
• Provides regulatory response support for health authority questions to support product approvals

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

Education: 

Minimum:  B.S. or higher in engineering (Chemical, Biomedical, or Mechanical) or related field

Experience:

Minimum:  2 years of direct experience working on medical devices or combination products (with B.S.) or 1 year of direct experience working on medical devices or combination products (with Ph.D/M.S.)

Preferred Qualifications:

Preferred:    Working knowledge of class II and III combination products/medical devices; device risk management, test method validation, reliability engineering, statistics (i.e. regression analysis); continuous improvement (i.e. six sigma green or black belt); tolerancing and dimensional analysis

Skills:

• Demonstrated critical thinking to identify underlying principles, reasons, or facts of information by breaking down information or data in separate parts and making decisions based on analysis.
• Demonstrated skills in multitasking and prioritizing group/departmental workload to meet multiple, and sometimes conflicting, customer demands and ability to allocate resources within a fast-paced environment
• Demonstrated successful communication and negotiation skills in order to manage conflicting and/or multiple demands, including ability to present to various level within an organization.
• Ability to utilize active listening skills to understand the concerns or reasoning in order to be responsive, gain trust, and build strategic relationships
• Ability to comprehend and apply technical and technological, financial and business information.  Ability to make sound business decisions regarding technical and personnel matters, while anticipating future needs and developing proactive organizational solutions. Working understanding of the business case and an appreciation of financial / analytical issues.
• Demonstrated planning and organizing skills to manage multiple tasks, set priorities, and meet deadlines
• Strong Project Management skills coupled with the ability to effectively manage and partner with subordinates, contractors and vendors.  Proven ability to simultaneously manage multiple projects and initiatives.
• Demonstrated ability to apply analytical skills to identify problems; recognize symptoms, causes, and alternate solutions and makes timely sound decisions even under risk and uncertainty.
• Knowledge of applicable laws and regulations regarding development and manufacturing of pharmaceuticals, including cGMP, DEA, FDA Guidance’s, ANDA Filing Requirements, ISO standards, etc.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay.  Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).  Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment.  Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Agency Notice:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions.  In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.